Occlusive devices

ABSTRACT

A system for treatment of an aneurysm includes an intrasaccular device that can be delivered using a catheter. The device can include at least one expandable structure adapted to transition from a compressed configuration to an expanded configuration when released into the aneurysm. The expandable structure can have a specific shape or porosity. Multiple expandable structures can also be used, in which case each of the expandable structures can have a unique shape or porosity profile. The morphology of the aneurysm and orientation of any connecting arteries can determine the type, size, shape, number, and porosity profile of the expandable structure used in treating the aneurysm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/725,768, filed Nov. 13, 2012, the entirety of which is incorporatedherein by reference.

BACKGROUND

1. Field of the InventionS

The present disclosure generally relates to a system and method fordelivering and deploying a medical device within a vessel, moreparticularly, it relates to a system and method for delivering anddeploying an endoluminal therapeutic device within the vasculature of apatient to embolize and occlude aneurysms, particularly, cerebralaneurysms.

2. Description of the Related Art

Walls of the vasculature, particularly arterial walls, may develop areasof pathological dilatation called aneurysms. As is well known, aneurysmshave thin, weak walls that are prone to rupturing. Aneurysms can be theresult of the vessel wall being weakened by disease, injury or acongenital abnormality. Aneurysms could be found in different parts ofthe body with the most common being abdominal aortic aneurysms and brainor cerebral aneurysms in the neurovasculature. When the weakened wall ofan aneurysm ruptures, it can result in death, especially if it is acerebral aneurysm that ruptures.

Aneurysms are generally treated by excluding the weakened part of thevessel from the arterial circulation. For treating a cerebral aneurysm,such reinforcement is done in many ways including: (i) surgicalclipping, where a metal clip is secured around the base of the aneurysm;(ii) packing the aneurysm with small, flexible wire coils (micro-coils);(iii) using embolic materials to “fill” or “pack” an aneurysm; (iv)using detachable balloons or coils to occlude the parent vessel thatsupplies the aneurysm; and (v) intravascular stenting.

In conventional methods of introducing a compressed stent into a vesseland positioning it within in an area of stenosis or an aneurysm, aguiding catheter having a distal tip is percutaneously introduced intothe vascular system of a patient. The guiding catheter is advancedwithin the vessel until its distal tip is proximate the stenosis oraneurysm. A guidewire positioned within an inner lumen of a second,inner catheter and the inner catheter are advanced through the distalend of the guiding catheter. The guidewire is then advanced out of thedistal end of the guiding catheter into the vessel until the distalportion of the guidewire carrying the compressed stent is positioned atthe point of the lesion within the vessel. Once the compressed stent islocated at the lesion, the stent may be released and expanded so that itsupports the vessel.

SUMMARY

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

Systems and procedures for treating aneurysms can include anintrasaccular device having one or more expandable components that canbe inserted into an aneurysm to facilitate a thrombotic, healing effect.The components can have a specific characteristics, including porosity,composition, material, shape, size, interconnectedness,inter-engagement, coating, etc. These characteristics can be selected inorder to achieve a desired treatment or placement of the intrasacculardevice.

The intrasaccular device can comprise a single component having two ormore sections that have an average porosity that is different from eachother. In some embodiments, the intrasaccular device can comprisemultiple components that each have an average porosity. In eitherembodiment, the intrasaccular device can be arranged within an aneurysmaccording to a desired porosity profile. The intrasaccular device can berepositioned as necessary within the aneurysm during expansion.

The intrasaccular device can optionally comprise one or more componentshaving a desired shape, which can allow a clinician to implant anintrasaccular device tailored to the aneurysm. A plurality ofindividual, independent components can operate collectively to form acomposite unit having one or more desired characteristics. Suchcomponents can have an interlocking structure, which can include aframing component, according to some embodiments.

The intrasaccular device, when used with a framing component, can enableexpandable components to be securely retained within an aneurysm. Aframing component can comprise a foam or braided structure. Further, oneor more expandable components can be inserted into a cavity of or formedby the framing component.

Additionally, the intrasaccular device can also be configured to providea plurality of interconnected expandable components, extending inlinear, planar, or three-dimensional arrays or matrices. These arrays ormatrices can be deployed in whole or in part into a target aneurysm,allowing a clinician to select portions of the array or matrix forimplantation.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as numbered embodiments (1, 2, 3, etc.) forconvenience. These are provided as examples and do not limit the subjecttechnology. It is noted that any of the dependent embodiments may becombined in any combination with each other or one or more otherindependent embodiments, to form an independent embodiment. The otherembodiments can be presented in a similar manner. The following is anon-limiting summary of some embodiments presented herein:

Embodiment 1

A device for treatment of an aneurysm, comprising a foam componenthaving first and second sections, the first section having an averageporosity different from an average porosity of the second section, thecomponent being expandable from a compressed configuration to anexpanded configuration when released into an aneurysm from a catheter.

Embodiment 2

The device of Embodiment 1, wherein the component is self-expanding toassume the expanded configuration thereof.

Embodiment 3

The device of Embodiment 1, wherein the component is adapted to expandupon exposure to a thermal agent.

Embodiment 4

The device of Embodiment 1, wherein the component is adapted to expandupon exposure to a chemical agent.

Embodiment 5

The device of Embodiment 1, wherein the first section comprises a firstmaterial and the second section comprises a second material differentfrom the first material, the first and second sections being coupled toeach other.

Embodiment 6

The device of Embodiment 5, wherein the first section is coupled to thesecond section by chemical bonding, by thermal bonding, or by mechanicalcrimping.

Embodiment 7

The device of Embodiment 1, wherein the component further comprises athird section coupled to the second section, the third section having anaverage porosity different from the porosity of the second section.

Embodiment 8

The device of Embodiment 7, wherein the third material is different fromthe first material.

Embodiment 9

The device of Embodiment 7, wherein the second section is coupled to thethird section using an adhesive.

Embodiment 10

The device of Embodiment 7, wherein the second section comprises asecond material and the third section comprises a third materialdifferent from the second material.

Embodiment 11

The device of Embodiment 7, wherein the third section porosity isdifferent from the first section porosity.

Embodiment 12

The device of Embodiment 11, wherein the first section comprises anaverage porosity of between about 1 μm and about 150 μm, and the thirdsection comprises an average porosity of between 150 μm and about 300μm.

Embodiment 13

The device of Embodiment 1, further comprising a transition zone betweenthe first and second sections, the transition zone having an averageporosity intermediate the porosities of the first and second sections.

Embodiment 14

The device of Embodiment 13, wherein the transition zone porosity variesspatially from about that of the first section to about that of thesecond section.

Embodiment 15

The device of Embodiment 13, wherein the porosity in the first andsecond sections each spatially varies progressively from an end of thefirst section to an opposite end of the second section.

Embodiment 16

The device of Embodiment 13, wherein the transition zone porositydecreases from the porosity of the first section to the porosity of thesecond section.

Embodiment 17

The device of Embodiment 1, wherein in the expanded configuration, thecomponent comprises a substantially spherical shape that is dividedcrosswise into the first and second sections.

Embodiment 18

The device of Embodiment 17, wherein the first and second sectionscorrespond to first and second hemispheres of the substantiallyspherical shape.

Embodiment 19

The device of Embodiment 17, further comprising a third section coupledto the second section, the first, second, and third sectionscollectively forming the substantially spherical shape.

Embodiment 20

The device of Embodiment 1, wherein the component further comprises abioactive coating.

Embodiment 21

The device of Embodiment 20, wherein the bioactive coating comprises athrombogenic drug.

Embodiment 22

The device of Embodiment 1, wherein the component further comprises anexpansion-limiting coating configured to control an expansion rate ofthe component.

Embodiment 23

The device of Embodiment 1, wherein the first section comprises anaverage porosity of between about 1 μm and about 100 μm, and the secondsection comprises an average porosity of between about 100 μm and about200 μm.

Embodiment 24

The device of Embodiment 1, wherein a shape of the component is selectedfrom the group consisting of cylinders, hemispheres, polyhedrons,prolate spheroids, oblate spheroids, plates, bowls, hollow structures,clover shapes, non-spherical surface of revolution, and combinationsthereof.

Embodiment 25

The device of Embodiment 24, further comprising a second foam componenthaving a shape selected from the group consisting of spheres, cylinders,hemispheres, polyhedrons, prolate spheroids, oblate spheroids, plates,bowls, hollow structures, clover shapes, non-spherical surface ofrevolution, and combinations thereof.

Embodiment 26

The device of Embodiment 25, wherein the foam component and the secondfoam component are different sizes from each other.

Embodiment 27

The device of Embodiment 25, wherein the foam component and the secondfoam component are different shapes from each other.

Embodiment 28

The device of Embodiment 25, wherein the foam component and the secondfoam component have mating structures configured to abut each other in acomplementary configuration and restrict at least degrees of freedom ofmotion of each of the foam component and the second foam component.

Embodiment 29

The device of Embodiment 25, further comprising a plurality ofadditional foam components having substantially spherical shapes.

Embodiment 30

A system for treatment of an aneurysm, comprising a plurality of foamcomponents being expandable from a compressed configuration to anexpanded configuration when released into an aneurysm from a catheter,each of the plurality of components having an average porosity that isdifferent from an average porosity of another of the plurality ofcomponents, the plurality of components being positionable within theaneurysm to form a composite foam component having a composite porosityconfigured to provide a therapeutic effect.

Embodiment 31

The system of Embodiment 30, wherein each of a first group of theplurality of components comprises a first average porosity, and each ofa second group of the plurality of components comprises a second averageporosity different from the first average porosity.

Embodiment 32

The system of Embodiment 31, wherein the first average porosity isbetween about 1 μm and about 100 μm, and the second average porosity isbetween about 100 μm and about 200 μm.

Embodiment 33

The system of Embodiment 30, wherein a shape of at least one of theplurality of components is substantially spherical.

Embodiment 34

The system of Embodiment 30, wherein a shape of at least one of theplurality of components is selected from the group consisting ofspheres, cylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.

Embodiment 35

The system of Embodiment 30, wherein each of the plurality of componentsis interconnected to another of the plurality of components via afilament.

Embodiment 36

The system of Embodiment 35, wherein each of the plurality of componentsis interconnected to at least two others of the plurality of components.

Embodiment 37

The system of Embodiment 30, wherein the plurality of components isself-expanding to assume the expanded configuration thereof.

Embodiment 38

The system of Embodiment 30, wherein the plurality of components isadapted to expand upon exposure to a thermal agent.

Embodiment 39

The system of Embodiment 30, wherein the plurality of components isadapted to expand upon exposure to a chemical agent.

Embodiment 40

The system of Embodiment 30, wherein at least one of the plurality ofcomponents comprises a bioactive coating.

Embodiment 41

The system of Embodiment 30, wherein at least one of the plurality ofcomponents comprises a thrombogenic drug.

Embodiment 42

The system of Embodiment 30, wherein at least one of the plurality ofcomponents comprises an expansion-limiting coating configured to controlan expansion rate of the component.

Embodiment 43

The system of Embodiment 30, wherein each of the plurality of componentsis different sizes from another of the plurality.

Embodiment 44

The system of Embodiment 30, wherein each of the plurality of componentsis different shapes from another of the plurality.

Embodiment 45

The system of Embodiment 30, wherein a first of the plurality ofcomponents and a second of the plurality of components have matingstructures configured to abut each other in a complementaryconfiguration and restrict at least degrees of freedom of motion of eachof the first and second of the plurality of components.

Embodiment 46

A device for treatment of an aneurysm, comprising a foam componenthaving a region of variable average porosity and a radiopaque marker,the marker being visible under imaging and positionable relative to theregion so as to facilitate identification and orientation of thecomponent when implanted into the aneurysm from a catheter, thecomponent being expandable from a compressed configuration to anexpanded configuration when released into the aneurysm.

Embodiment 47

The device of Embodiment 46, wherein the region comprises a firstsection and a second section having an average porosity different froman average porosity of the first material.

Embodiment 48

The device of Embodiment 47, wherein the region further comprises athird section adjacent to the second section, the third section havingan average porosity different from the porosity of the second section.

Embodiment 49

The device of Embodiment 48, wherein the second section is coupled tothe third section by chemical bonding, by thermal bonding, or bymechanical crimping.

Embodiment 50

The device of Embodiment 48, wherein the third section porosity isdifferent from the first section porosity.

Embodiment 51

The device of Embodiment 46, wherein the region comprises a firstmaterial and a second material different from the first material, thefirst and second materials being coupled to each other.

Embodiment 52

The device of Embodiment 51, wherein the region further comprises athird material different from the first material.

Embodiment 53

The device of Embodiment 46, wherein the marker comprises a materialblended into the component such that the component is visible underimaging.

Embodiment 54

The device of Embodiment 53, wherein the marker comprises bisumuth ortantalum blended with a foam material to form the component.

Embodiment 55

The device of Embodiment 46, wherein the marker is coupled to anexterior of the component.

Embodiment 56

The device of Embodiment 55, wherein the marker comprises a coating or amaterial that is bonded or mechanically coupled to the component.

Embodiment 57

The device of Embodiment 46, wherein a shape of the component isselected from the group consisting of cylinders, hemispheres,polyhedrons, prolate spheroids, oblate spheroids, plates, bowls, hollowstructures, clover shapes, non-spherical surface of revolution, andcombinations thereof.

Embodiment 58

The device of Embodiment 57, further comprising a second foam componenthaving a shape selected from the group consisting of spheres, cylinders,hemispheres, polyhedrons, prolate spheroids, oblate spheroids, plates,bowls, hollow structures, clover shapes, non-spherical surface ofrevolution, and combinations thereof.

Embodiment 59

The device of Embodiment 58, wherein the foam component and the secondfoam component are different sizes from each other.

Embodiment 60

The device of Embodiment 58, wherein the foam component and the secondfoam component are different shapes from each other.

Embodiment 61

The device of Embodiment 58, wherein the foam component and the secondfoam component have mating structures configured to abut each other in acomplementary configuration and restrict at least degrees of freedom ofmotion of each of the foam component and the second foam component.

Embodiment 62

The device of Embodiment 58, further comprising a plurality ofadditional foam components having substantially spherical shapes.

Embodiment 63

A method for treatment of an aneurysm, comprising: advancing a foamcomponent through a catheter lumen, the component comprising a firstsection having a different average porosity than an average porosity ofa second section; releasing the component into the aneurysm; allowingthe component to expand from a compressed configuration to an expandedconfiguration within the aneurysm; and positioning the component withinthe aneurysm such that the first section is positioned away from theaneurysm neck and the second section is positioned adjacent to a neck ofthe aneurysm.

Embodiment 64

The method of Embodiment 63, wherein the positioning comprises rotatingthe component.

Embodiment 65

The method of Embodiment 63, wherein the positioning comprisesmaintaining a position of the component relative to the aneurysm neckduring expansion to the expanded configuration.

Embodiment 66

The method of Embodiment 63, wherein the aneurysm is disposed adjacentat bifurcation of a parent vessel into two efferent vessels, and whereinthe positioning further comprises positioning the second sectionadjacent to the bifurcation and permitting flow through the bifurcationand into at least one of the first or second efferent vessels.

Embodiment 67

The method of Embodiment 66, wherein the first section comprises anaverage porosity of between about 1 μm and about 150 μm.

Embodiment 68

The method of Embodiment 66, wherein the second section comprises anaverage porosity of between about 100 μm and about 200 μm.

Embodiment 69

The method of Embodiment 63, wherein the component further comprises athird section disposed between the first and second sections, the thirdsection having an average porosity different than the porosity of thesecond section, wherein the positioning comprises positioning thecomponent such that the first section is positioned at a fundus of theaneurysm and the third section is positioned between the fundus and theaneurysm neck.

Embodiment 70

The method of Embodiment 63, wherein the positioning comprises aligninga radiopaque marker relative to the aneurysm to position the secondsection adjacent to the aneurysm neck.

Embodiment 71

The method of Embodiment 70, wherein the aligning comprises aligning themarker with a fundus of the aneurysm.

Embodiment 72

The method of Embodiment 63, further comprising injecting a liquidembolic material into the aneurysm after positioning the component.

Embodiment 73

The method of Embodiment 63, further comprising implanting a supportstructure into the aneurysm before releasing the component into theaneurysm, and wherein the releasing comprises releasing the componentthrough a wall of the support structure into the aneurysm.

Embodiment 74

The method of Embodiment 73, wherein the support structure comprises asubstantially enclosed interior cavity, and the releasing furthercomprises releasing the component into the interior cavity.

Embodiment 75

A system for treatment of an aneurysm, comprising: a first foamcomponent being expandable from a compressed configuration to anexpanded configuration when released into the aneurysm, the firstcomponent having a first shape when in the expanded configuration; and asecond foam component, separate from and freely movable relative to thefirst component, being expandable from a compressed configuration to anexpanded configuration when released into the aneurysm, the secondcomponent having a second shape when in the expanded configuration;wherein at least one of the first and second shapes is selected from thegroup consisting of cylinders, hemispheres, polyhedrons, prolatespheroids, oblate spheroids, plates, bowls, hollow structures, clovershapes, non-spherical surface of revolution, and combinations thereof.

Embodiment 76

The system of Embodiment 75, wherein the first and second shapes aredifferent from each other.

Embodiment 77

The system of Embodiment 75, wherein the first and second components aredifferent sizes from each other.

Embodiment 78

The system of Embodiment 75, further comprising a third foam component,the third component having a third shape different from the first shape.

Embodiment 79

The system of Embodiment 78, wherein the third shape is substantiallyspherical.

Embodiment 80

The system of Embodiment 78, wherein the first, second, and thirdcomponents are different sizes from each other.

Embodiment 81

The system of Embodiment 78, wherein the first, second, and thirdcomponents have different shapes from each other.

Embodiment 82

The system of Embodiment 75, further comprising third, fourth, and fifthfoam components, each of the third, fourth, and fifth components havingshapes different from those of the first and second shapes.

Embodiment 83

The system of Embodiment 75, further comprising third, fourth, and fifthfoam components, each of the third, fourth, and fifth components havingsizes different from those of the first and second components.

Embodiment 84

The system of Embodiment 75, wherein the first and second componentshave first and second mating structures configured to abut each other ina complementary configuration.

Embodiment 85

The system of Embodiment 84, wherein the mating structures can operateto restrict at least two degrees of freedom of motion of the othercomponent.

Embodiment 86

The system of Embodiment 84, wherein in the complementary configuration,the first component restricts at least two degrees of freedom of motionof the second component.

Embodiment 87

The system of Embodiment 84, wherein in the complementary configuration,the first component restricts at least three degrees of freedom ofmotion of the second component.

Embodiment 88

The system of Embodiment 87, wherein the first component restricts four,five, or six degrees of freedom of motion of the second component.

Embodiment 89

The system of Embodiment 84, wherein in the complementary configuration,the first and second components are interconnected to form a compositestructure.

Embodiment 90

The system of Embodiment 84, wherein in the complementary configuration,the first and second components are interconnected to form a compositestructure, and wherein the first and second components have differentaverage porosities from each other.

Embodiment 91

The system of Embodiment 84, further comprising a third foam componenthaving a third mating structure configured to abut at least the firstmating structure, wherein in the complementary configuration, the firstcomponent restricts at least two degrees of freedom of motion of thethird component.

Embodiment 92

The system of Embodiment 91, wherein the first component restricts four,five, or six degrees of freedom of motion of the third component.

Embodiment 93

The system of Embodiment 75, wherein the first and second componentshave different average porosities from each other.

Embodiment 94

The system of Embodiment 75, wherein the first component comprises afirst coating and the second component is substantially free of thefirst coating.

Embodiment 95

The system of Embodiment 75, wherein the component further comprises abioactive coating.

Embodiment 96

The system of Embodiment 95, wherein the bioactive coating comprises athrombogenic drug.

Embodiment 97

The system of Embodiment 75, wherein the component further comprises anexpansion-limiting coating configured to control an expansion rate ofthe component.

Embodiment 98

A system for treatment of an aneurysm, comprising a plurality ofseparate and independently expandable components each being expandablefrom a compressed configuration to an expanded configuration whenreleased into the aneurysm, each of the components having shapesdifferent from each other, wherein the shapes are selected from thegroup consisting of cylinders, hemispheres, polyhedrons, prolatespheroids, oblate spheroids, plates, bowls, hollow structures, clovershapes, non-spherical surface of revolution, and combinations thereof.

Embodiment 99

The system of Embodiment 98, wherein the components are different sizesfrom each other.

Embodiment 100

The system of Embodiment 98, further comprising at least one additionalcomponent that is substantially spherical.

Embodiment 101

The system of Embodiment 98, further comprising a plurality ofadditional components that are substantially spherical.

Embodiment 102

The system of Embodiment 101, wherein the plurality of additionalcomponents are different sizes from each other.

Embodiment 103

The system of Embodiment 98, wherein at least two of the components havemating structures configured to abut each other in a complementaryconfiguration for restricting freedom of motion of the components.

Embodiment 104

The system of Embodiment 103, wherein the components each have matingstructures configured to abut each other in a complementaryconfiguration.

Embodiment 105

The system of Embodiment 104, wherein in the complementaryconfiguration, the components are interconnected to form a compositestructure.

Embodiment 106

The system of Embodiment 103, wherein in the complementaryconfiguration, the components are interconnected to form a compositestructure, and wherein the components have different porosities fromeach other.

Embodiment 107

A method for treatment of an aneurysm, comprising: positioning a distalopening of a catheter adjacent to an aneurysm; and releasing a pluralityof separate and independently foam components into the aneurysm; whereinshapes of the plurality of components are selected from the groupconsisting of cylinders, hemispheres, polyhedrons, prolate spheroids,oblate spheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.

Embodiment 108

The method of Embodiment 107, wherein the releasing comprises releasingthe plurality of components based on a shape of the aneurysm.

Embodiment 109

The method of Embodiment 108, further comprising selecting the pluralityof components based on the shape of the aneurysm.

Embodiment 110

The method of Embodiment 107, wherein the releasing comprisesinterconnecting at least two components to create a composite structure.

Embodiment 111

The method of Embodiment 107, wherein the releasing comprises releasingthe plurality of components into the aneurysm to fill the aneurysm suchthat as a composite, the plurality of components provides a lowerporosity adjacent to a neck of the aneurysm relative to a fundus of theaneurysm.

Embodiment 112

The method of Embodiment 107, further comprising imaging the aneurysm.

Embodiment 113

The method of Embodiment 112, wherein the imaging comprises determininga shape of the aneurysm to select the plurality of components.

Embodiment 114

The method of Embodiment 112, further comprising repositioning a firstof the plurality of components within the aneurysm after the firstcomponent has been released into the aneurysm.

Embodiment 115

The method of Embodiment 114, wherein the repositioning comprisesrepositioning the first component such that the plurality of components,as a composite, is arranged within the aneurysm to provide a lowerporosity adjacent to a neck of the aneurysm relative to a fundus of theaneurysm.

Embodiment 116

The method of Embodiment 107, further comprising, prior to releasing theplurality of components into the aneurysm, implanting a framing deviceinto the aneurysm.

Embodiment 117

The method of Embodiment 116, wherein the releasing comprises releasingthe plurality of components into a cavity of the framing device.

Embodiment 118

A method for treatment of an aneurysm, comprising: positioning a distalopening of a catheter adjacent to the aneurysm; and advancing a framingdevice into the aneurysm, the framing device having an interior cavityand an exterior surface for contacting a wall of the aneurysm; and whileat least a portion of the device exterior surface is in contact with theaneurysm wall, releasing at least one expandable component into thedevice cavity; wherein the framing device comprises at least one of afoam or a braided structure.

Embodiment 119

The method of Embodiment 118, wherein the aneurysm is a saccularaneurysm and before releasing the at least one expandable component, thedevice is expanded such that the exterior surface contacts an innersurface of the aneurysm having a cross-sectional profile greater than apassing profile of a neck of the aneurysm.

Embodiment 120

The method of Embodiment 118, wherein the releasing comprises causingthe device to expand into contact with the aneurysm wall.

Embodiment 121

The method of Embodiment 118, wherein the device comprises asubstantially closed three-dimensional expanded shape.

Embodiment 122

The method of Embodiment 118, wherein the component comprises at leastone of a foam, a coil, or a braided structure.

Embodiment 123

The method of Embodiment 121, wherein the three-dimensional shape isselected from the group consisting of spheres, cylinders, hemispheres,polyhedrons, prolate spheroids, oblate spheroids, non-spherical surfaceof revolution, and combinations thereof.

Embodiment 124

The method of Embodiment 118, wherein the device comprises forquadrants, and the releasing comprises causing at least a portion ofeach quadrant to contact the aneurysm wall.

Embodiment 125

The method of Embodiment 124, wherein the device comprises asubstantially spherical expanded shape.

Embodiment 126

The method of Embodiment 118, wherein the device comprises an opening tothe device cavity, and the releasing comprises injecting the at leastone expandable component into the device cavity through the deviceaperture.

Embodiment 127

The method of Embodiment 126, wherein the device comprises a braidedmaterial and the opening is an opening formed between filaments of thebraided material.

Embodiment 128

The method of Embodiment 126, wherein the framing device has a closedend and an open end opposite the closed end, the open end forming theopening, and wherein the releasing advancing comprises aligning theopening with a neck of the aneurysm.

Embodiment 129

The method of Embodiment 128, wherein the open end comprises a pluralityof filament ends extending into the device cavity and forming theopening, the plurality of filament ends collectively forming a tubularportion extending into the device cavity, wherein the releasingcomprises permitting the at least one expandable component to expandwithin the device cavity such that the tubular portion is deflected intocontact with an inner wall of the device, thereby closing the opening.

Embodiment 130

The method of Embodiment 118, wherein the releasing comprises releasinga plurality of expandable components into the aneurysm such that as acomposite, the plurality of expandable components provides a loweraverage porosity adjacent to a neck of the aneurysm relative to anaverage porosity at a fundus of the aneurysm.

Embodiment 131

The method of Embodiment 118, wherein the at least one expandablecomponent comprises a shape selected from the group consisting ofcylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.

Embodiment 132

The method of Embodiment 118, wherein the releasing comprises releasingat least one coil into the device cavity.

Embodiment 133

The method of Embodiment 118, wherein the releasing comprises releasingat least one expandable component into the device cavity.

Embodiment 134

The method of Embodiment 133, wherein the at least one expandablecomponent comprises an expandable composite comprising first and secondportions having different porosities from each other.

Embodiment 135

A method for treatment of an aneurysm, comprising: implanting a stentinto a lumen of a parent vessel from which an aneurysm arises such thatthe stent extends across at least a portion of the aneurysm; andreleasing at least one expandable component into an inner volume of theaneurysm between a wall of the aneurysm and an outer surface of thestent; wherein the expandable component comprises at least one of a foamor a braided structure.

Embodiment 136

The method of Embodiment 135, wherein the aneurysm comprises a fusiformaneurysm.

Embodiment 137

The method of Embodiment 135, wherein the aneurysm comprises a wide-neckaneurysm.

Embodiment 138

The method of Embodiment 135, wherein the portion comprises a neck.

Embodiment 139

The method of Embodiment 135, wherein the at least one expandablecomponent comprises a plurality of expandable components, and thereleasing comprises releasing the plurality based on relative sizes ofthe expandable components.

Embodiment 140

The method of Embodiment 139, further comprising selecting the at leastone expandable component based on the shape of the inner volume.

Embodiment 141

The method of Embodiment 140, wherein the at least one expandablecomponent comprises a shape selected from the group consisting ofcylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.

Embodiment 142

The method of Embodiment 135, wherein the at least one expandablecomponent comprises a first portion having an average porosity greaterthan that of a second portion thereof, and the releasing comprisespositioning the at least one expandable component such that the firstportion abuts an outer surface of the stent device and the secondportion extends along an inner wall of the aneurysm.

Embodiment 143

The method of Embodiment 135, wherein the releasing comprises releasinga plurality of expandable components into the inner volume.

Embodiment 144

The method of Embodiment 135, wherein the aneurysm inner volume extendsaround a circumference of the stent device, and the releasing comprisesdepositing a plurality of expandable components into the inner volumearound the circumference of the stent device.

Embodiment 145

The method of Embodiment 144, wherein at least one of the plurality ofexpandable components comprises a flat or cylindrically shaped surface,and the releasing comprises positioning the at least one of theplurality of expandable components such that the flat or cylindricallyshaped surface substantially conforms to an outer surface of the stentdevice.

Embodiment 146

A system for treatment of an aneurysm, comprising: an intrasacculardevice comprising first and second expandable components adapted totransition from a compressed configuration to an expanded configurationwhen deployed into the aneurysm, the first and second components beinginterconnected by a non-helical coupling such that the first and secondcomponents can be advanced as an interconnected unit, into the aneurysm;wherein the first component comprises at least one of a shape or anaverage porosity different from a shape or an average porosity of thesecond component.

Embodiment 147

The system of Embodiment 146, wherein the first component shape isselected from the group consisting of cylinders, hemispheres,polyhedrons, prolate spheroids, oblate spheroids, plates, bowls, hollowstructures, clover shapes, non-spherical surface of revolution, andcombinations thereof.

Embodiment 148

The system of Embodiment 146, wherein the second component comprises asubstantially spherical shape.

Embodiment 149

The system of Embodiment 146, wherein at least one of the first orsecond components comprises a foam or a braided structure.

Embodiment 150

The system of Embodiment 146, wherein at least one of the first orsecond components comprises a coil.

Embodiment 151

The system of Embodiment 146, wherein the first component comprises anaverage porosity of between about 1 μm and about 100 μm and the secondcomponent comprises an average porosity of between about 100 μm andabout 200 μm

Embodiment 152

The system of Embodiment 146, further comprising a third componentinterconnected with the second component such that the first, second,and third components are interconnected in series.

Embodiment 153

The system of Embodiment 146, wherein the coupling interconnecting thefirst and second components comprises a filament.

Embodiment 154

The system of Embodiment 146, wherein the coupling has a preset shapesuch that in an expanded position, the first and second components arespaced relative to each other at a preset orientation.

Embodiment 155

The system of Embodiment 146, further comprising an introducer sheathconfigured to receive the device therein such that the device can beloaded into the guide catheter for delivery to the aneurysm.

Embodiment 156

A system for treatment of an aneurysm, comprising: an intrasacculardevice comprising at least three expandable components adapted totransition from a compressed configuration to an expanded configurationwhen deployed into the aneurysm, each of the at least three componentsbeing interconnected to at least two of the at least three componentssuch that at least three expandable components can be advanced as aninterconnected unit, into the aneurysm.

Embodiment 157

The system of Embodiment 156, wherein the at least three expandablecomponents comprises at least four expandable components.

Embodiment 158

The system of Embodiment 157, wherein at least two of the at least fourexpandable components is interconnected with at least three of the atleast four expandable components such that the device comprises amulti-planar shape.

Embodiment 159

The system of Embodiment 156, wherein the at least three components areinterconnected by filaments.

Embodiment 160

The system of Embodiment 156, wherein at least three components areinterconnected by filaments having preset shapes such that in anexpanded position, the at least three components are spaced relative toeach other at a preset orientation.

Embodiment 161

The system of Embodiment 156, wherein the device comprises at least onecentral expandable component positioned such that, when the device is inan expanded configuration, the central expandable component is centrallyinterconnected with a plurality of the expandable components.

Embodiment 162

The system of Embodiment 161, wherein the at least one centralexpandable component has an expanded size greater than an expanded sizeof each remaining one of the plurality of components.

Embodiment 163

The system of Embodiment 161, wherein the at least one centralexpandable component has an average porosity greater than an averageporosity of each remaining one of the plurality of the components.

Embodiment 164

The system of Embodiment 158, wherein the multi-planar shape comprises apolyhedron.

Embodiment 165

The system of Embodiment 164, wherein the multi-planar shape comprises apyramid.

Embodiment 166

The system of Embodiment 164, wherein the multi-planar shape comprises aprism.

Embodiment 167

The system of Embodiment 156, wherein a first component of the at leastthree components comprises a shape or an average porosity different thanthat of a second component of the at least three components.

Embodiment 168

The system of Embodiment 156, wherein the first component shape isselected from the group consisting of cylinders, hemispheres,polyhedrons, prolate spheroids, oblate spheroids, plates, bowls, hollowstructures, clover shapes, non-spherical surface of revolution, andcombinations thereof.

Embodiment 169

The system of Embodiment 156, wherein the second component comprises asubstantially spherical shape.

Embodiment 170

The system of Embodiment 156, wherein the first component comprises anaverage porosity of between about 1 μm and about 100 μm, and the secondcomponent comprises an average porosity of between about 100 μm andabout 200 μm.

Embodiment 171

The system of Embodiment 156, further comprising an introducer sheathconfigured to receive the device therein such that the device can beloaded into the guide catheter for delivery to the aneurysm.

Embodiment 172

A method for treatment of an aneurysm, comprising: advancing anintrasaccular device toward the aneurysm through a lumen of a catheter,the device comprising a plurality of expandable components each adaptedto transition from a compressed configuration to an expandedconfiguration when deployed into the aneurysm from the catheter, each ofthe plurality of components being interconnected by a coupling.

Embodiment 173

The method of Embodiment 172, further comprising: advancing the deviceinto the aneurysm such that a first component is disposed within theaneurysm and a second component, interconnected with the first componentby the coupling, is disposed within the catheter lumen; severing thecoupling between the first and second components to release the firstcomponent into the aneurysm; retaining the second component within thelumen; and withdrawing the catheter.

Embodiment 174

The method of Embodiment 172, further comprising advancing a pluralityof expandable components into the aneurysm prior to the severing.

Embodiment 175

The method of Embodiment 172, wherein each of the plurality ofcomponents is interconnected in series by the coupling.

Embodiment 176

The method of Embodiment 172, wherein the severing comprises proximallywithdrawing the catheter relative to a second catheter such that thecoupling between the first and second components is pinched between adistal end of the catheter and a rim of the second catheter.

Embodiment 177

The method of Embodiment 172, wherein the plurality of expandablecomponents is arranged in descending size, and the advancing comprisesallowing an initial expandable component deployed into the aneurysm toexpand prior to advancing a subsequent expandable component into theaneurysm.

Embodiment 178

The method of Embodiment 177, wherein the advancing comprises observinga fit of expanded components within the aneurysm to determine whether toadvance additional components into the aneurysm.

Embodiment 179

The method of Embodiment 178, wherein the device comprises a radiopaquematerial.

Embodiment 180

The method of Embodiment 178, wherein the couplings between theplurality of expandable components comprise a radiopaque material.

Embodiment 181

The method of Embodiment 178, wherein each of the plurality ofexpandable components of the device comprises a radiopaque material.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thedisclosure and together with the description serve to explain theprinciples of the subject technology.

FIG. 1 is a schematic illustration depicting an aneurysm within a bloodvessel, into which an intrasaccular device has been implanted, accordingto some embodiments.

FIG. 2 is a schematic view of reticulated foam, which can be used in theintrasaccular device accordance with some embodiments.

FIG. 3 is a schematic view an intrasaccular device having a specificporosity, according to some embodiments.

FIG. 4 is a schematic view of an intrasaccular device comprising twoportions having different porosities, according to some embodiments.

FIG. 5 is an enlarged view of a transition zone of the intrasacculardevice shown in FIG. 4, wherein the transition zone comprises animmediate transition between different porosities, according to someembodiments.

FIG. 6 is an enlarged view of the transition zone of the intrasacculardevice shown in FIG. 4, wherein the transition zone comprises a gradualtransition between different porosities, according to some embodiments.

FIG. 7 is a schematic view of an intrasaccular device comprising threeportions arranged in a specific porosity profile, according to someembodiments.

FIG. 8 is a schematic view of an intrasaccular device comprising threeportions arranged in a specific porosity profile, according to someembodiments.

FIG. 9 is a schematic view of an intrasaccular device comprising fourportions having different porosities, according to some embodiments.

FIG. 10 is a schematic view of an intrasaccular device having channelsextending therethrough, according to some embodiments.

FIG. 11 is a schematic view of an intrasaccular device having a channelextending therethrough, according to some embodiments.

FIGS. 12A-12R are views illustrating alternate configurations for thefoam structures of the intrasaccular device;

FIGS. 13-15 illustrate hollow structures of an intrasaccular device,according to some embodiments.

FIGS. 16-18 illustrate interlocking structures of an intrasacculardevice, according to some embodiments.

FIGS. 19-21 illustrate alternate embodiments of the intrasaccular deviceincorporating coated foam structures.

FIG. 22-25 illustrate a delivery system and a procedure for deliveringan intrasaccular device, according to some embodiments.

FIG. 26 illustrates an intrasaccular device having a radiopaque materialand positioned within an aneurysm, according to some embodiments.

FIGS. 27-30 illustrate intrasaccular devices positioned within ananeurysm based on a porosity profile, according to some embodiments.

FIGS. 31A-34 illustrate alternative engagement mechanisms for thedelivery system shown in FIG. 22, for engaging one or more expandablecomponents, according to some embodiments.

FIG. 35 illustrates a delivery system for delivering an intrasacculardevice, according to some embodiments.

FIG. 36 illustrates a delivery system for delivering an intrasacculardevice comprising a plurality of expandable components, according tosome embodiments.

FIG. 37 illustrates a delivery system, advanceable along a guide wire,for delivering an intrasaccular device comprising a plurality ofexpandable components, according to some embodiments.

FIG. 38 illustrates an intrasaccular device having a specific shape anda radiopaque material positioned within a saccular aneurysm, accordingto some embodiments.

FIG. 39 illustrates an intrasaccular device comprising a plurality ofexpandable components positioned within a saccular aneurysm, accordingto some embodiments.

FIG. 40 illustrates an intrasaccular device comprising a plurality ofinterlocking expandable components positioned within a saccularaneurysm, according to some embodiments.

FIG. 41 illustrates an intrasaccular device comprising a plurality ofexpandable components positioned within a saccular aneurysm, accordingto some embodiments.

FIG. 42 illustrates an intrasaccular device comprising a plurality ofexpandable components extending across a fusiform aneurysm, according tosome embodiments.

FIG. 43 illustrates a schematic view of a procedure in which an embolicliquid and an intrasaccular device comprising single expandablecomponent are inserted into an aneurysm, according to some embodiments.

FIG. 44 illustrates a schematic view of a procedure in which an embolicliquid and an intrasaccular device comprising a plurality of expandablecomponents are inserted into an aneurysm, according to some embodiments.

FIG. 45 illustrates a delivery procedure for delivering coils or foamwithin an interior of an intrasaccular framing device, according to someembodiments.

FIG. 46 illustrates a partial cross-sectional view of the intrasaccularframing device as similarly shown in FIG. 45, packed with coils,according to some embodiments.

FIG. 47 illustrates a partial cross-sectional view of the intrasaccularframing device as similarly shown in FIG. 45, packed with at least onefoam component, according to some embodiments.

FIG. 48 illustrates another embodiment of an intrasaccular framingdevice, packed with at least one foam component, according to someembodiments.

FIG. 49 illustrates yet another embodiment of an intrasaccular framingdevice, packed with at least one foam component, according to someembodiments.

FIGS. 50-52 are schematic views of different intrasaccular framingdevices, according to some embodiments.

FIGS. 53-56 illustrate embodiments of the intrasaccular deviceincorporating a strip of foam structures.

FIGS. 57A-57C illustrate cross-sectional shapes that can be employed,alone or in combination with each other, in the intrasaccular structuresshown in FIGS. 53-56.

FIG. 58A illustrates an embodiment of an intrasaccular device comprisinga plurality of interconnected expandable components in a compressedstate, according to some embodiments.

FIG. 58B illustrates the intrasaccular device of FIG. 58A comprising aplurality of interconnected expandable components in an expanded state,according to some embodiments.

FIG. 59A illustrates an embodiment of an intrasaccular device comprisinga layer of interconnected expandable components in a compressed state,according to some embodiments.

FIG. 59B illustrates another embodiment of an intrasaccular devicecomprising a layer of interconnected expandable components in acompressed state, according to some embodiments.

FIG. 60A illustrates an embodiment of an intrasaccular device comprisinga three-dimensional array of interconnected expandable components in acompressed state, according to some embodiments.

FIG. 60B illustrates another embodiment of an intrasaccular devicecomprising a three-dimensional array of interconnected expandablecomponents in a compressed state, according to some embodiments.

FIG. 61-63 illustrate a delivery system and procedure for delivering aplurality of interconnected expandable components, according to someembodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances,well-structures and techniques have not been shown in detail so as notto obscure the subject technology.

Intrasaccular implant devices and procedures for treating aneurysms canbe improved by manipulating one or more physical characteristics of theimplant material. Such characteristics can include the porosity,composition, material, shape, size, interconnectedness,inter-engagement, coating, etc. By modifying one or more suchcharacteristics, the morphology or attributes of a target aneurysm andorientation of any connecting arteries can be specifically consideredand addressed to achieve superior treatment.

According to some embodiments, the porosity, composition, or material ofthe intrasaccular device can facilitate in the treatment of an aneurysm.The intrasaccular device can comprise an expandable component. Theintrasaccular device can expand from a first, compressed configurationto a second, expanded configuration when released into the aneurysm.

Optionally, the intrasaccular device can comprise an expandablecomponent having an average porosity that changes from a first end ofthe component to a second end opposite the first end. Optionally, theintrasaccular device can comprise a composite structure having first andsecond sections or materials having different porosities. For example,the first and second sections can be separated by a transition zone. Thetransition zone can comprise an immediate change in porosity or agradual transition in which the porosity spatially varies between afirst porosity and a second porosity from one end of the transition zoneto another, opposite end of the transition zone.

As used herein, “porosity” can generally refer to an average porosity,which can be sampled across a given portion or section of an expandablecomponent. “Porosity” can be defined as the ratio of the volume of thepores of in a component to the volume of the component as a whole.Porosity can be measured by a fluid displacement test. For example,liquid or gas testing can be used, as necessary or desirable, accordingto skill in the art. In some embodiments, a chromatography chamber canbe used to measure displacement of a gas within the chamber, enablingthe calculation of an average porosity of a given intrasaccular deviceor portion thereof. Other methods and systems can be used to measureporosity of portions of or the entirety of an expandable component.

In some embodiments, a composite structure of the intrasaccular devicecan comprise three materials having different porosities. Further, thecomposite structure of the intrasaccular device can comprise for, five,six, or more different materials having different porosities.

According to some embodiments, one or more of intrasaccular devices canbe released into a target aneurysm and, in some embodiments,specifically oriented relative to the aneurysm ostium or neck and/or oneor more perforating vessels (e.g., perforating arteries or arterioles)adjacent to the aneurysm.

In some embodiments, the intrasaccular device can be repositioned withinthe aneurysm as the device is expanding. The repositioning of the devicecan allow a clinician to position a lower porosity section of the deviceadjacent to the neck of the aneurysm. The repositioning of the devicecan also allow a clinician to position a higher average porosity sectionof the device adjacent to one or more perforating vessels (e.g.,perforating arteries or arterials) adjacent to the aneurysm. Therepositioning of the device can also allow a clinician to position alower porosity portion of the device adjacent to a bifurcation. Therepositioning of the device can also allow a clinician to position ahigher average porosity portion of the device toward or in the fundus ofthe aneurysm.

Intrasaccular implant devices and procedures for treating aneurysmsdislosed herein can also comprise manipulating a shape or size of theintrasaccular device. According to some embodiments, a single expandablecomponent having a specific or selected shape or size, which can betailored to the shape or size of the aneurysm, can be implanted into ananeurysm. Further, multiple expandable components, each having such aspecific or selected shape or size can also be implanted into ananeurysm. The shape or size of the expandable component(s) can beselected from a variety of spherical or non-spherical shapes. Each shapecan be solid or hollow.

According to some embodiments, a composite intrasaccular device can beprovided that comprises at least two mating expandable components (e.g.,a plurality of interconnectable or engageable expandable components).Each of the expandable components can comprise one or more engagementstructures configured to interact with a corresponding engagementstructure of another mating expandable component.

For example, the mating expandable components can each comprise anengagement structure configured to interact with a correspondingengagement structure of another mating expandable component. The matingexpandable components can be delivered into the aneurysm and arranged insitu such that the engagement structures are aligned and interconnectedappropriately such that the expandable components are mated. In someembodiments, the mating of the expandable components can interlock thecomponents as a unit. For example, expansion of a portion of a componentwithin a recess of another component can cause the components to beinterlocked with each other. Further, in some embodiments, the matingcomponents can restrict at least one degree of freedom of movement ofanother component.

According to some embodiments in which a plurality of expandablecomponents is used, the expandable components (whether interconnected bywires or filaments, or not interconnected, thereby moving independentlyof each other) can be arranged in a pattern to provide a compositecomponent. The composite component can provide desired characteristicsthat may be difficult to achieve in a single component formed from asingle, continuous piece of material.

A variety of delivery systems and procedures can be implemented todeliver an intrasaccular device having a specific size or shape and, insome embodiments, having a plurality of expandable components. Examplesof these systems and procedures are discussed further herein.

In accordance with some embodiments of the delivery procedure, thetarget aneurysm can be imaged and analyzed in order to determine athree-dimensional shape of the aneurysm. Based on the shape of thetarget aneurysm, one or more expandable components can be selected,having a unique porosity, composition, material, shape, size,interconnectedness, inter-engagement, or coating, etc. Imaging devicescan include 3-D CTA or MRI (MRA) imaging, through which the size andshape of the aneurysm can be ascertained. Such imaging can provide abasis for selection of one or more correspondingly shaped intrasacculardevice(s) for insertion within the aneurysm. Different combinations ofexpandable components or their characteristics can be used.

Optionally, in some embodiments, the intrasaccular device can have apredetermined configuration, whether or not the intrasaccular device hasonly a single or multiple expandable components. The predeterminedconfiguration can be based on typical aneurysm shapes, thereby allowingselection of a specific intrasaccular device. However, individualcomponents of an intrasaccular device can also be arranged based ontheir properties. Accordingly, the clinician can determine the shape ofthe aneurysm and create a desired intrasaccular device configuration fortreating the aneurysm.

In some embodiments, an expandable component of an intrasaccular devicemay be molded or manufactured into a variety of geometrical or partialgeometrical shapes.

For example, in order to accommodate a variety of aneurysmconfigurations, the shape or size of the expandable component(s) can beselected from a variety of spherical or non-spherical shapes, including,cylinders, hemispheres, noodles, polyhedrons (e.g., cuboids (types),tetrahedrons (e.g. pyramids), octahedrons, prisms), coils, prolatespheroids, oblate spheroids, plates (e.g., discs, polygonal plates),bowls (e.g., an open container, such as a hollow, hemisphericalcontainer or other open, hollow containers, whether hemispherical,rounded, or otherwise), hollow structures (e.g., a container of anyshape with an inner cavity or void, which can be, for example, greaterin size than a width of any of the walls of the structure), clovershapes (a plurality of radially extending protrusions, having rounded orsmooth corners), non-spherical surfaces of revolution (e.g., toruses,cones, cylinders, or other shapes rotated about a center point or acoplanar axis), and combinations thereof. Each shape(s) can be solid orhollow.

In accordance with some embodiments, at least a portion of theintrasaccular device can comprise a coating or material for enhancingtherapeutic, expansive, or imaging properties or characteristics of atleast one or every expandable component of the intrasaccular device.

In some embodiments, the intrasaccular device can be configured suchthat an expandable component thereof is coated with a biocompatiblematerial to promote endothelialization or provide a therapeutic effect.

Optionally, the expandable component can also comprise anexpansion-limiting coating that slows expansion of the component fromits natural rate of expansion to a slower rate of expansion such that inthe process of expanding, the position of the component can be adjustedwithin the aneurysm or the component can be removed from the aneurysm,if necessary. Examples of polymers that can be used asexpansion-limiting coatings can include hydrophobic polymers, organicnon-polar polymers, PTFE, polyethylene, polyphenylene sulfide, oils, andother similar materials.

Various delivery systems and procedures can be implemented fordelivering an intrasaccular device comprising one or more expandablecomponents, as discussed herein. Further, a system and method areprovided for delivery of an intrasaccular device to an aneurysm and/orrecapturing the device for removal or repositioning.

Intrasaccular implant devices and procedures for treating aneurysms cancomprise interconnecting individual components of the intrasacculardevice. According to some embodiments, a plurality of expandablecomponents can be interconnected along a wire, filament, or otherdisconnectable or breakable material. The expandable components can beconnected in a linear configuration, a planar matrix, or in athree-dimensional matrix. The expandable components of suchinterconnected linear, planar, or three-dimensional matrices can besized and configured in accordance with desired porosity, size, shape,radiopacity, or other characteristics disclosed herein.

In some embodiments, methods are provided by which interconnectedexpandable components can be released into an aneurysm. Theinterconnected components can be preconfigured (e.g., a plurality ofcomponents can be joined together to form a single, unitary device, or aselect plurality of components can be removed from a larger strand orarray of components) prior to implantation and later inserted into adelivery catheter. Thereafter, the entire strand or assembly ofinterconnected expandable components of the intrasaccular device can beejected or released into the aneurysm and allowed to expand within theanuerysm.

However, in accordance with some embodiments, an entire strand or arrayof components can be loaded into a delivery catheter, and whileimplanting and observing the packing behavior, a clinician can determinethat a select portion of the interconnected expandable components issufficient for a given aneurysm. Thereafter, the select portion of theinterconnected expandable components can be broken or cut in situ so asto be released into the aneurysm.

Additionally, although in some embodiments, a single expandablecomponent can be used alone to fill the aneurysm and provide a desiredpacking density, a plurality of expandable components can also be usedto fill the aneurysm and provide a desired packing density. Optionally,a liquid embolic and/or a framing component can be used in combinationwith one or more expandable components to facilitate delivery,engagement with the aneurysm, or increase of the packing density. Any ofthese embodiments can allow increased packing density to avoidrecanalization of the aneurysm.

Referring now to the drawings, FIG. 1 illustrates an embodiment of anintrasaccular device 10 positioned within an aneurysm 12 in a bloodvessel 14. The intrasaccular device 10 can be particularly adapted foruse in the tortuous neurovasculature of a subject for at least partialdeployment in a cerebral aneurysm.

A cerebral aneurysm may present itself in the shape of a berry, i.e., aso-called berry or saccular aneurysm, which is a bulge in theneurovascular vessel. Berry aneurysms may be located at bifurcations orother branched vessels. Other types of aneurysms, including fusiformaneurysms, can also be treated using embodiments of the intrasacculardevices disclosed herein.

The intrasaccular device 10 can comprise at least one expandablecomponent. In some embodiments, the intrasaccular device 10 can comprisea plurality of expandable components. Further, a given expandablecomponent of the intrasaccular device 10 can have one or more differentcharacteristics than another of the expandable components of theintrasaccular device 10.

An expandable component can be formed from a material that can be highlycompressed and later expanded when released into the aneurysm andcontacted by a fluid, such as a fluid within the aneurysm. In someembodiments, the expandable component can be formed at least in part ofbiocompatible, solid foam. As disclosed herein, “foam” can include asolid or semisolid gel, a swellable material (whether swellable uponhydration or swellable/self-expanding without hydration), a materialhaving pores and interstices. “Foam” can include hydrophobic orhydrophilic materials. “Foam” can also include materials that can behighly compressed and configured to expand upon contact with a fluid,upon exposure to a thermal agent, upon exposure to a chemical agent, orself-expanding, upon release from engagement with the deliverymechanism. In some embodiments, the foam material can be configured toexpand by about two, three, four, five, six, seven, eight, nine, ten,eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen,eighteen, nineteen, twenty, or more times its collapsed size whenexpanding to its expanded size.

For example, FIG. 2 illustrates a schematic view of a foam material 20.Suitable foam materials can comprise biocompatible foams such as a PVA(polyvinyl alcohol). Further, suitable foam materials can comprisereticulated foam. “Reticulated” foam can, in some embodiments, comprisea random arrangement of holes that has irregular shapes and sizes or anonrandom arrangement of holes that has regular, patterned shapes andsizes. Suitable foam is also known under the trade name PacFoam, madeavailable through UFP Technologies of Costa Mesa, Calif. In someembodiments, the foam material from which the expandable component isformed can be configured to include at least about 20 pores per inch(“PPI”), at least about 30 PPI, at least about 40 PPI, at least about 50PPI, at least about 60 PPI, at least about 70 PPI, or at least about 80PPI, or combinations thereof.

Other materials can also be used to form one or more portions of anintrasaccular device or an expandable component thereof. Such materialscan include, but are not limited to polyvinyl alcohol (PVA) materials,water-soluble synthetic polymers, such as poly ethylene glycol (PEG),polyvinyl pyrrolidone (PVP), and other similar materials.

The porosity of the expandable component may vary along any portion(s)thereof, including any combination of pore sizes of 1 micron or greater.Further, the pore sizes can range from about 1 μm to about 400 μm, fromabout 5 μm to about 300 μm, from about 8 μm to about 200 μm, from about10 μm to about 150 μm, from about 15 μm to about 80 μm, or in someembodiments, from about 20 μm to about 50 μm. Further, at least aportion or section of the device can comprise an average porosity ofbetween about 1 μm and about 150 μm. Further, at least a portion orsection can comprise an average porosity of between about 100 μm andabout 200 μm. Furthermore, at least a portion or section can comprise anaverage porosity of between about 200 μm and about 300 μm. When acomposite expandable component is formed using multiple sections orportions, each section or portion can have an average porosity withinany of the ranges discussed above.

According to some embodiments, in a compressed state, an expandablecomponent of the intrasaccular device may be compressed down to 50%,40%, 30%, 20%, 10% or less of its expanded state (which can be measuredby its maximum diameter or cross-sectional dimension) for deliverythrough a standard microcatheter. In some embodiments, the foam materialcan be configured to expand by about two to twenty times its collapsedsize when expanding to its expanded size.

In the event the intrasaccular device is not self-expandable, butexpandable through a chemical reaction, a chemical may be introducedwithin the lumen of the delivery catheter for delivery to theintrasaccular device. In the alternative, the delivery catheter mayinclude a separate lumen for introduction of the catalyst. Thermallyexpansive foam may be activated through introduction of heated saline orsome other suitable biocompatible fluid through any of theaforementioned lumens of the delivery catheter. In the alternative, aheating element may be incorporated within the delivery catheter todeliver heat to the foam structure to cause corresponding expansion. Asuitable heating element, identified schematically as reference numeral,may include resistive element(s), a microwave antenna, radio-frequencymeans, ultrasonic means or the like.

As noted above, some embodiments of the expandable component can beconfigured to provide a specific porosity profile. The porosity profilecan comprise a single, consistent average porosity throughout the entireexpandable component, or multiple average porosity zones, portions, ormaterials having different average porosities that are joined to form acomposite expandable component.

For example, the embodiment illustrated in FIG. 3 can be configured tohave a low average porosity structure. For purposes of illustration, lowporosity structures are illustrated in the figures using hexagonalpatterns with larger spaces compared to hexagonal patterns with smallerspaces, which are used to illustrate medium and high porositystructures. Low porosity structures can provide higher packingdensities, which can facilitate thrombogenesis by providing higherresistance to flow therethrough. When such low porosity structures areimplanted into an aneurysm, such structures can substantially pack theaneurysm with a relatively high packing density, thereby isolating theaneurysm from the parent vessel and minimizing blood flow velocitywithin the aneurysm while supporting the aneurysm wall.

Conversely, as porosity increases, the packing density decreases, whichcompared to low porosity structures, provides less support forthrombogenesis due to lower resistance to flow therethrough.Nevertheless, the realization of some embodiments disclosed herein isthat high porosity structures can also support the aneurysm wall,beneficially aid in healing and thrombogenesis for select aneurysmmorphologies, permit flow to other vessels (e.g., branch vessels,perforating arteries, or arterioles), and/or permit the introduction ofother materials, such as a liquid embolic, etc.

Further, in some embodiments, composite, variable, or multi-porosityexpandable components (whether using a single expandable componenthaving multiple porosities or using multiple expandable components eachhaving different porosities) can advantageously allow the intrasacculardevice to mimic natural function of the vasculature while promotinghealing through thrombogenesis, pressure moderation or reduction, oraneurysm deflation. Further, in embodiments using a single expandablecomponent, the single expandable component can be configured toadvantageously secure the intrasaccular device within a wide-neckaneurysm by facilitating engagement with a sufficient amount of theaneurysm wall, thereby avoiding dislodgement or herniation of the devicefrom the aneurysm into the parent vessel.

FIG. 3 illustrates an expandable component 50 having a relatively lessdense or high porosity due to a larger pore size. As noted above, thefoam component 50 can permit some blood flow therethrough to maintainbranch vessels while still providing support for the aneurysm wall.Further, in accordance with some embodiments, the expandable component50 or a portion of the expandable component 50 can be packed with aliquid embolic during or subsequent to placement of the intrasacculardevice. The injection of a liquid embolic can increase the overallpacking density within the expandable component 50.

One suitable liquid embolic is the Onyx™ liquid embolic systemmanufactured by Covidien LP, Irvine, Calif. Onyx™ liquid embolic systemis a non-adhesive liquid used in the treatment of brain arteriovenousmalformations. Onyx™ liquid embolic system is comprised of an EVOH(ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethylsulfoxide), and suspended micronized tantalum powder to provide contrastfor visualization under fluoroscopy. Other liquid embolic solutions arealso envisioned.

FIGS. 4-9 illustrate additional embodiments of expandable components.For example, FIG. 4 illustrates an expandable component 60 having firstand second portions 62, 64. The first and second portions 62, 64 can beformed from different materials. For example, the first portion 62 cancomprise a higher average porosity first material, and the secondportion 64 can comprise a lower average porosity second material. Thefirst and second portions 62, 64 can be coupled to each other by anychemical, thermal, or mechanical bonding methods known in the art orarising hereafter. The first and second portions 62, 64 can bepermanently attached to each other or releasably, upon expansion,attached to each other.

FIGS. 5-6 illustrate enlarged views of a transition zone 66 of theexpandable component 60 of FIG. 4. In accordance with some embodiments,FIG. 5 illustrates that a transition zone 66 a can comprise animmediate, abrupt transition between the porosities of the first andsecond portions 62, 64. The transition zone 66 a provides an open flowpathway between the first and second portions 62, 64. Thus, thetransition zone 66 a may not act as a barrier to fluid flow. However, insome embodiments, the transition zone 66 a can provide at least apartial or full barrier to fluid flow between the first and secondportions 62, 64. In such embodiments, the composite structure of theexpandable component 60 may incorporate individual, separately formedsegments or sections of material that are later joined together tocreate a composite unit or whole. The individual segments or first andsecond portions 62, 64 may comprise the same material (such as any ofthose mentioned herein), or incorporate a combination of differentmaterials. The first and second portions 62, 64 may be bonded by anychemical, thermal, or mechanical methods known in the art.

FIG. 6 illustrates that a transition zone 66 b can comprise anintermediate portion 68 having an average porosity that is higher thanthe average porosity of the second section 64, but lower than theaverage porosity of the first section 62. The transition zone 66 bprovides an open flow pathway between the first, second, and/orintermediate portions 62, 64, 68. Thus, similar to the transition zone66 a, the transition zone 66 b may not act as a barrier to fluid flow.However, in some embodiments, the transition zone 66 b can provide atleast a partial or full barrier to fluid flow between the first, second,and/or intermediate portions 62, 64, 68. In such embodiments, theintermediate portion 68 can have a porosity that gradually transitionsspatially from a low porosity to a high porosity, or vice versa. Thetransition zone 66 b can be formed by varying the gas used in thefabrication of the variable porosity structure. Further, duringmanufacturing of the expandable component 60, regions within the blankcan be identified based on an average porosity and the expandablecomponent can be trimmed therefrom. In some embodiments, certain regionscan be identified that have a porosity that varies spatially from oneend of the region to another, opposite end.

FIGS. 7-9 illustrate schematic views of additional embodiments ofexpandable components shown in FIGS. 1-4. These figures illustrateexpandable components that each include a composite structure having twoor more foam segments with different respective porosities (or poredensities), sizes, and/or shapes.

For example, FIG. 7 illustrates an expandable component 80 having first,second, and third portions 82, 84, 86. The second portion 84 cancomprise a lower porosity than the first and third portions 82, 86. Insome embodiments, the first and third portions 82, 86 can comprise thesame porosity (e.g., the first and third portions 82, 86 can comprisethe same material or be formed or cut from the same material). However,in some embodiments, the first and third portions 82, 86 can comprisedifferent porosities (e.g., the first and third portions 82, 86 cancomprise different materials or be formed or cut from differentmaterials). Additionally, the first, second, and third portions 82, 84,86 can comprise different sizes and/or shapes or have substantiallyidentical sizes and/or shapes. Size and shape characteristics can beconfigured as discussed below, in accordance with some embodiments.

FIG. 8 similarly illustrates an expandable component 90 having first,second, and third portions 92, 94, 96. In general, the second portion 94comprises a higher porosity than the first and third sections 92, 96.Additionally, FIG. 9 also illustrates expandable component 100 havingfirst, second, third, and fourth sections 102, 104, 106, 108, which caneach have distinct porosities, shapes, and/or sizes. The porosity, size,or shape of the portions of the expandable components 90, 100 can beconfigured as similarly discussed above with respect to FIG. 7.Accordingly, the discussion of such characteristics will not be repeatedexcept to indicate that FIGS. 8-9 illustrate that some embodiments canincorporate varied porosities, sizes, and shapes different from thoseillustrated FIG. 7.

The foam composites may be formed to provide different support and/orflow profiles. As addressed herein, a material, such as bismuth ortantalum, can be blended with the foam to provide radiopacity. Also,radiopaque markers can be attached to the foam by bonding ormechanically crimping them to the foam.

As noted above, in some embodiments, only a single expandable componentwould be required for introduction into an aneurysm. In someembodiments, this may prove advantageous over conventional methodologiessuch as the insertion of, for example, multiple embolic coils, bysignificantly reducing time for performance of the embolizationprocedure.

Additionally, in some embodiments, multiple expandable components can beprovided for insertion into an aneurysm. For example, a plurality ofexpandable components, having different average porosities, can beimplanted into an aneurysm and have a composite or cumulative porosityprofile spatially across the aneurysm, which can allow the plurality ofexpandable components to operate as a unit in much the same way as asingle expandable component, if packing the same aneurysm itself, wouldoperate. Such embodiments are discussed in greater detail below in FIGS.36-42. The expandable components can be arranged and positioned within alumen of the catheter or otherwise arrange for delivery into theaneurysm. The size of each expandable component can be compressed to afraction of its normal, expanded size and delivered into the targetaneurysm.

Further, in some embodiments, the expandable component(s) can includeone or more flow regions. The flow region can be used alone orcombination with any of the variable porosity profiles disclosed herein,including those illustrated in FIGS. 4-9.

For example, FIGS. 10-11 illustrate expandable components having atleast one flow region. FIG. 10 illustrates an expandable component 30having a pair of flow regions 32 formed in a body 34. FIG. 11 similarlyillustrates another embodiment of an expandable component 40 having asingle flow region 42 formed in a body 44. While the body 34, 44 canhave a substantially constant porosity that impedes fluid flow andgenerally promotes thrombogenesis, the flow regions 32, 42 can beconfigured such that fluid flow through the flow regions is possible.For example, the flow regions 32, 42 of the expandable components 30, 40can provide a flow path for blood or enable performance of a secondaryprocedure, such as the introduction of an embolic, anti-inflammatory,antibiotic, or thrombogenic agent and/or permit deployment of emboliccoils within the expandable components 30, 40. Either of thesecomponents 30, 40 may allow blood to communicate to a side branch vesselthrough areas of the expandable component with large porosity whilestill providing stasis in the aneurysm.

According to some embodiments, the flow regions 32, 42 can comprise apassage, channel, or elongate void within the body 34, 44. Further, inembodiments wherein the flow regions 32, 42 comprise a material, thematerial of the flow regions 32, 42 can have a much higher porosity thanthat of the surrounding areas within the body 34, 44. Although FIGS.10-11 illustrate only single or dual flow regions, some embodiments canbe configured to comprise three, four, or more flow regions formedtherein.

In some embodiments, the flow region can be separated from otherportions of the body by a partial or full barrier. For example, the flowregion can comprise a lumen formed through the body and the lumen cancomprise an inner wall (not shown) extending therealong. The inner wallcan comprise a continuous surface. However, the inner wall can alsocomprise one or more perforations extending through the wall, by whichthe lumen of the flow region is in fluid communication with thesurrounding areas of the body. Thus, the flow region can provideisolated flow through the body or a flow that is in communication withother areas of the body of the expandable component.

FIGS. 12A-12R illustrate various examples of shapes that can be used inaccordance with some embodiments. Variations, whether by proportions,combinations, or other modifications of the disclosed shapes can bemade, as taught herein. Without limitation, the shapes illustrated inFIGS. 12A-12R can comprise a sphere 120, a hemisphere 121, a cuboid 122,a pyramid 123, an octahedron 124, an octagonal prism 125, a pentagonalprism 126, a coil 127, a prolate spheroid 128, an oblate spheroid 129, aclover plate 130, a star plate 131, a paraboloid of revolution 132, ahollow sphere 133, a bowl 134, a torus 135, a cylinder 136, a cone 137,or combinations thereof.

In particular, in some embodiments, an intrasaccular device can beprovided that comprises first and second expandable components of whichat least one has a shape selected from the group consisting ofcylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.Additional expandable components can be provided that have substantiallyspherical shapes.

In accordance with some embodiments, an intrasaccular device cancomprise first and second expandable components having different shapes.Further, the first and second expandable components can have differentsizes. A third expandable component can be used, which can have the sameor different sizes or shapes compared to either or both of the first andsecond expandable components. Thus, the first, second, and thirdexpandable components can each have a different size and/or shapecompared to each other. Such principles can apply to additionalcomponents, such as fourth, fifth, sixth components, and so forth.

Further, the shapes mentioned above can be solid or at least partiallyhollow (e.g., having a cavity or void therewithin). Hollow expandablecomponents can comprise braided structures (e.g., braided spheres), foamstructures, and the like. A hollow expandable component can be releasedinto the aneurysm by itself or in combination with other occlusivematerial, such as a liquid embolic, additional expandable components, orcoils.

For example, FIGS. 13-15 illustrate hollow structures that can be usedin accordance with embodiments of an intrasaccular device. FIGS. 13-15each illustrates an intrasaccular device 150 a, 150 b, 150 c. Eachdevice 150 a, 150 b, 150 c can comprise a shape having a hollow body 152a, 152 b, 152 c, which can in turn define a cavity 154 a, 154 b, 154 c.The hollow body 152 a, 152 b, 152 c can be advantageous at least becauseit can enable the intrasaccular devices 150 a, 150 b, 150 c to have amore compact compressed state than a corresponding intrasaccular device(having an equivalent size when expanded) that is not hollow. Further,because the body 152 a, 152 b, 152 c is hollow, the intrasacculardevices 150 a, 150 b, 150 c can provide greater packing volumes withinthe aneurysm while using less material. Furthermore, because theintrasaccular device 150 a, 150 b, 150 c can be compressed,comparatively, to a smaller size in its compressed state, theintrasaccular device 150 a, 150 b, 150 c can be delivered through asmaller microcatheter.

Additionally, in some embodiments, the intrasaccular device 150 a, 150b, 150 c can be configured to comprise an aperture 156 a, 156 b, 156 cin communication with the cavity 154 a, 154 b, 154 c to permitintroduction of, e.g., at least one additional expandable component, aliquid embolic, or embolic coils to further pack and/or support theaneurysm. In lieu of an aperture 156 a, 156 b, 156 c, the clinician mayperforate the intrasaccular device 150 a, 150 b, 150 c before or duringthe procedure. In such a capacity or procedure, the intrasaccular device150 a, 150 b, 150 c can function as an intrasaccular framing device.

For example, the intrasaccular device 150 a, 150 b, 150 c can beexpanded within the aneurysm such that the intrasaccular device 150 a,150 b, 150 c extends across the neck of the aneurysm with the aperture156 a, 156 b, 156 c being accessible through the neck (see e.g., FIGS.40 and 44). According to some embodiments, although the intrasacculardevice extends across the neck, it may not touch or contact the neck ofthe aneurysm. Further, in embodiments that comprise an open end, theintrasaccular device 150 a, 150 b, 150 c can be oriented such that theopen end faces the fundus of the aneurysm and the closed end (includingthe aperture 156 a, 156 b, 156 c) extends across the neck of theaneurysm.

Alternately, the aperture 156 a, 156 b, 156 c may permit theintroduction of a second smaller expandable component having a hollowinterior. A third expandable component, smaller than the secondexpandable component, may then be introduced into the hollow interior ofthe second expandable component. Additional smaller foam structures maybe added in a similar manner. FIGS. 13, 14, and 15 illustrate spheroid,ellipsoid and prism-shaped foam structures 402, respectively.

In alternate embodiments, the intrasaccular device 150 a, 150 b, 150 cmay receive any of the aforedescribed solid foam structures of the priorembodiments until the cavity 154 a, 154 b, 154 c is packed to thedesired capacity.

FIGS. 16-18 illustrate interlocking structures of an intrasacculardevice, according to some embodiments. For example, FIGS. 16-17illustrate a composite intrasaccular device 160 a, 160 b having firstand second portions or components 162 a, 162 b, 164 a, 164 b. The firstand second portions 162 a, 162 b, 164 a, 164 b can comprise respectiveengagement structures 166 a, 166 b, 168 a, 168 b.

The intrasaccular devices 160 a, 160 b shown in FIGS. 16-17 can beconfigured such that the respective engagement structures 166 a, 166 b,168 a, 168 b provide a loose fit with each other when the first andsecond portions 162 a, 162 b, 164 a, 164 b are in their expanded states.However, according to some embodiments, the protrusions of therespective engagement structures 166 a, 166 b, 168 a, 168 b can beoversized relative to the recess of the respective engagement structures166 a, 166 b, 168 a, 168 b, such that the protrusion expands to createan interference fit inside the recess, thereby securing the firstportion 162 a, 162 b relative to the second portion 164 a, 164 b in theexpanded states. In such embodiments, the protrusion and recess can beguided towards each other as the first and second portions 162 a, 162 b,164 a, 164 b expand within the aneurysm. In addition to the engagementstructures shown, other engagement structures can be provided, such as aball and socket, slots, pins, etc.

Further, in embodiments having only two interconnecting portions, suchinterconnecting portions can be configured to restrict at least twodegrees of freedom of motion of the opposing portion. Motion can berestricted in two or more of the following directions: up-and-downtranslation, forward and backward translation, left and righttranslation, side to side pivoting or rolling, left and right rotatingor yawing, and forward and backwards tilting or pitching. Further, insome embodiments, such as those illustrated in FIGS. 16-17, at leastthree degrees of the freedom of motion of a portion can be restricted.For example, the interconnection between portions of such embodimentscan restrict four, five, or all six degrees of freedom of motion of agiven portion.

FIG. 18 illustrates an intrasaccular device 180 having a plurality ofinterconnecting portions 182, 184, 186. These interconnecting portions182, 184, 186 can be configured to abut each other in a complementaryconfiguration, such as to provide a composite structure. In someembodiments, the interconnecting portions 182, 184, 186 can beconfigured to restrict at least two, three, four, five, or six degreesof freedom of motion of another component.

The mating expandable components, such as those embodiments illustratedin FIGS. 16-18 can be delivered into the aneurysm and arranged in situsuch that the engagement structures are aligned and interconnectedappropriately such that the expandable components are mated. In someembodiments, the mating of the expandable components can interlock thecomponents as a composite structure or unit, as in FIG. 16.

As noted above, in accordance with some embodiments, at least a portionof the intrasaccular device can comprise a coating or material forenhancing therapeutic, expansive, or imaging properties orcharacteristics of at least one or every expandable component of theintrasaccular device.

The intrasaccular device can be configured such that an expandablecomponent thereof is coated with a biocompatible material to promoteendothelialization or provide a therapeutic effect.

For example, FIG. 19 illustrates an alternate embodiment of the presentdisclosure. In accordance with this embodiment, the intrasaccular device190 comprising an expandable component 192 that can be coated and/orembedded with at least one coating 194, such as a bioactive material oragent.

The coating 194 may include thrombogenic coatings such as fibrin,fibrinogen or the like, anti-thrombogenic coatings such as heparin (andderivatives thereof), urukinase or t-PA, and endothelial promotingcoatings or facilitators such as, e.g., VEGF and RGD peptide, and/orcombinations thereof. Drug eluting coatings and a drug eluting foamcomposite, such as anti-inflammatory or antibiotic, coatings are alsoenvisioned. These drug eluting components may include nutrients,antibiotics, anti-inflammatory agents, antiplatelet agents, anestheticagents such as lidocaine, and anti-proliferative agents, e.g. taxolderivatives such as paclitaxel. Hydrophilic, hygroscopic, andhydrophobic materials/agents are also envisioned.

As also noted above, in some embodiments, the expandable component canalso comprise an expansion-limiting coating that slows expansion of thecomponent from its natural rate of expansion to a slower rate ofexpansion such that in the process of expanding, the position of thecomponent can be adjusted within the aneurysm or the component can beremoved from the aneurysm, if necessary. Examples of polymers that canbe used as expansion-limiting coatings can include hydrophobic polymers,organic non-polar polymers, PTFE, polyethylene, polyphenylene sulfide,oils, and other similar materials.

In embodiments, only specific segments of the intrasaccular device maybe embedded or coated with an agent to provide desired characteristicsto the expandable component(s). For example, as depicted in FIG. 20, anintrasaccular device 200 can comprise a non-thrombogenic coating 202 maybe applied to a lower half 204 of the expandable component 206 tominimize clotting at this location. Such coatings may be desirable inaneurysms located at a bifurcation such that blood flow to brancharteries is permitted through the segment of the foam structure havingthe non-thrombogenic coating. The coated area 202 may be a differentcolor than the remaining portion of the expandable component 206 toassist the surgeon in identifying this area.

Optionally, the coated area 202 can also comprise radiopaque material toassist the surgeon in visualization and placement of the expandablecomponent 206 in a desired orientation relative to the aneurysm. Theexpandable component 206 can have radiopacity characteristics either byadding radiopaque filler to the material (which in some embodimentscomprises a foam material), such as bismuth, or attaching radiopaquemarkers. Alternatively, a radiopaque material can be attached to theexpandable component 206, such as by dipping, spraying, or otherwisemechanically, chemically, or thermally attached, injected into, orblended into to the expandable component 206.

FIG. 21 illustrates another embodiment of the intrasaccular devicesillustrated in FIGS. 19-20. In FIG. 21, an intrasaccular device 220 isshown that comprises has a star-shaped expandable component 222 whichmay be partially or fully coated and/or embedded with a material 224,such as any of the aforedescribed agents. The star shape can provideincreased surface area due to the presence of the undulations 226 in theouter surface of the expandable component 222.

Once the expandable component is delivered into the aneurysm, it canexpand back to its full size or expanded state, confined within the neckof the aneurysm with minimal herniation within the parent vessel. Thefoam could be self-expandable, chemically expandable, thermallyexpandable, or expandable in response to pH changes or to light. Shapememory foams such as polyurethane foam can be used.

Various delivery systems and procedures can be implemented fordelivering an intrasaccular device comprising one or more expandablecomponents, as discussed herein. Further, a system and method areprovided for delivery of an intrasaccular device to an aneurysm and/orrecapturing the device for removal or repositioning.

For example, in accordance with some embodiments, FIGS. 22-25 illustratea delivery system and a procedure for implanting an intrasacculardevice. In the illustrated embodiment, a delivery catheter 300 isadvanced within a vessel 302 until a distal end 304 of the deliverycatheter 300 is positioned adjacent to a target site, such as ananeurysm 306.

A carrier assembly 320 can be configured to engage an intrasacculardevice 330 and deliver the intrasaccular device 330 into the aneurysm306. The carrier assembly 320 can comprise a core member 322 and anengagement member 324. The core member 322 can be interconnected withthe engagement member 324. The engagement member 324 can comprise atleast two arm members 340 having a closed position (see FIG. 22) and anopen position (see FIG. 23). In the closed position, the arm members 340can be engaged with at least a portion of the intrasaccular device 330to facilitate distal advancement and retention of the intrasacculardevice 330 within the lumen of the catheter 300.

The carrier assembly 320, disposed within a lumen of the deliverycatheter 300, can be advanced distally through the catheter 300 untilreaching the distal end 304 of the catheter 300. Upon reaching thedistal end 304, the carrier assembly 320 can be actuated to release anintrasaccular device 330 into the aneurysm 306, as shown in FIG. 23.

The arm members 340 can be spring-loaded or configured to spring openfrom the closed position upon being advanced out of or distally beyondthe distal end 304 of the catheter 300. However, the arm members 340 canalso be manually actuated using a proximal control mechanism, therebyallowing the arm members 340 to continue engaging the intrasacculardevice 330 even after the arm members 340 have moved out of the lumen ofthe catheter 300. For example, such a proximal control mechanism cancomprise a proximally extending wire coupled to a first of the armmembers 340, the proximal retraction of which causes the first armmember 342 retract into the catheter 300, thus releasing theintrasaccular device 330. Various other control mechanisms, such asthose disclosed herein, can also be implemented in accordance with someembodiments.

After the intrasaccular device 330 has been released into the aneurysm306, the intrasaccular device 330 can begin to expand. The clinician cancarefully monitor the orientation of the intrasaccular device 330relative to the neck or surrounding the vasculature of the aneurysm 306.

According to some embodiments, if the intrasaccular device 330 has aspecific characteristic, such as a porosity profile, coating, shape,etc., intended for placement in a certain location of the aneurysm 306,the clinician can position the intrasaccular device 330 by manuallyrotating, moving, maintaining the position of, or otherwise adjustingthe position of the intrasaccular device 330 within the aneurysm 306 asthe intrasaccular device 330 expands. This procedure is illustrated inFIGS. 24-25. Thus, by gently manipulating at least one of the armmembers 340, the clinician can contact the intrasaccular device 330 toensure proper orientation of the intrasaccular device 330 within theaneurysm 306. Although the manipulation of the position of theexpandable device is shown in the context of the carrier assembly 320 inFIGS. 22-25, the position of the expandable device can be manipulatedusing various other deployment or delivery devices, such as those shownin FIGS. 31A-37 or FIGS. 61-63.

In the performance of such procedures, the intrasaccular device 330 canbeneficially be coated with an expansion-limiting coating, such as thosediscussed above. In such embodiments, the expansion-limiting coating canallow the intrasaccular device 332 slowly expand, thus providing theclinician with a greater, and in some cases, a specified or expectedperiod of time after releasing the intrasaccular device 330 to adjustthe position of the intrasaccular device 330 within the aneurysm 306.

FIG. 26 illustrates the placement of an intrasaccular device 370 withinan aneurysm 306. The intrasaccular device 370 can comprise a radiopaquematerial 372. The radiopaque material 372 can be located at a specificend of the intrasaccular device 370 (in this case, on a first portion374 of the intrasaccular device 370, which has a lower porosity than asecond portion 376 thereof). In the illustration of FIG. 26, theintrasaccular device 370 is in an intermediate expanded state (i.e., ithas not yet fully expanded), and as the device 370 expands, theclinician can adjust its position based on a visualization of theradiopaque material 372. The clinician can visualize the orientation ofdifferent sections or portions of an intrasaccular device relative tothe neck or surrounding vasculature of an aneurysm, and here, align theradiopaque material 372 with the neck 380 of the aneurysm 306 (or insome embodiments, a fundus of the aneurysm 306) in order to maintain thelower porosity first portion 374 of the intrasaccular device 370adjacent to or extending across the aneurysm neck 380.

FIGS. 27-30 illustrate different aneurysm configurations and surroundingvasculature that may be treated best by achieving a specific orientationof an intrasaccular device within the aneurysm.

For example, FIG. 27 illustrates an intrasaccular device 390 orientedsuch that a low porosity section 392 thereof is positioned or extendsacross the neck 380 of the aneurysm 306, with a higher porosity section396 positioned in the fundus of the aneurysm 306. FIG. 27 also providesan illustration of the final result of the process described above withrespect to FIGS. 22-25. Thus, after continued expansion, theintrasaccular device 330 shown in FIGS. 22-25 can achieve the positionor state of expansion illustrated in FIG. 27.

FIG. 28 illustrates an artery 500 having an aneurysm 502 and aperforating vessel 504 extending through the aneurysm 502 adjacent to aneck 506 of the aneurysm 502. In such circumstances, an intrasacculardevice 520 can be positioned within the aneurysm 502 such that a highporosity section 522 extends across the neck 506 of the aneurysm 502 inorder to permit blood flow into the perforating vessel 504, asillustrated with arrows 530.

FIG. 29 illustrates an artery 550 having an aneurysm 552 and aperforating vessel 554 extending from the fundus of the aneurysm 552. Insuch situations, an intrasaccular device 560 can be positioned withinthe aneurysm 552 such that a first, high porosity section or channel 562of the intrasaccular device 560 provides a fluid pathway for blood toflow through the neck 564 of the aneurysm 552 toward and into theperforator vessel 554, as shown by arrow 570. Additionally, theintrasaccular device 560 can be configured to comprise one or more lowporosity sections 572, 574 that can tend to induce thrombosis andprotect the aneurysm wall.

FIG. 30 illustrates an intrasaccular device 590 oriented such that a lowporosity section 592 thereof is positioned or extends across the neck594 of an aneurysm 596 located at a vessel bifurcation. As illustrated,a higher porosity section 598 can be positioned in the fundus of theaneurysm 596. Thus, flow through the bifurcation, as shown by arrows 600can be diverted using the low porosity section 592, thereby relievingpressure on the aneurysm 596.

Referring now to FIGS. 31A-34, engagement mechanisms for a delivery andrecapture system, as shown in FIG. 22, are provided. These engagementmechanisms can provide secure engagement and release of one or moreexpandable components. Further, the system can recapture the device forremoval or repositioning.

As discussed above with respect to the engagement mechanism of FIG. 22,the engagement mechanisms illustrated in FIGS. 31A-34 can move betweenclosed and open positions in order to facilitate engagement with anddelivery of an intrasaccular device into an aneurysm.

FIGS. 31A-31B illustrate a system and method for delivery anintrasaccular device to an aneurysm and/or recapturing the device forremoval or repositioning. In one embodiment, the delivery system mayinclude an introducer catheter or sheath 630. A delivery/retrievalmember 680 can be disposed within a lumen of the catheter 630. Thedelivery/retrieval member 680 may include an elongated element 682having a plurality of gripping elements 684 at one end. Thedelivery/retrieval member 680 can be dimensioned to traverse thelongitudinal lumen of the introducer sheath 630. The gripping elements684 can be adapted to open and close about the intrasaccular device 650.In some embodiments, the gripping elements 684 can be normally biased toan open position.

In some embodiments, the delivery/retrieval member 680 can comprise theAlligator Retrieval Device, manufactured by Covidien LP, generallyrepresented in FIGS. 31A-31B. The Alligator Retrieval Device can includea flexible wire having a plurality of gripping arms or elements, e.g.,four arms, at the distal end of the flexible wire. Other embodiments forthe gripping elements 58 include a clover leaf design, fish hook design,or dissolvable coupling, as shown in FIGS. 31A-34, respectively.

In use, an access catheter is advanced within the neurovasculature as isconventional in the art. A suitable microcatheter adaptable fornavigation through the tortuous neurovascular space to access thetreatment site is disclosed in commonly assigned U.S. Pat. No.7,507,229, the entire contents of which are hereby incorporated herein.

The gripping elements 684 of the delivery/retrieval member 680 arepositioned about the intrasaccular device 650 (FIG. 31A), and thedelivery/retrieval member 680 is withdrawn into the introducer sheath630 such that the gripping elements 684 move inwardly during engagementwith the inner wall surface of the introducer sheath 630 to compress thefoam structure of the intrasaccular device 650 as depicted in FIG. 31B.The intrasaccular device 650 is withdrawn into the introducer sheath630. The introducer sheath 630 with the delivery/retrieval member 682and intrasaccular device 650 positioned therein is advanced through theaccess catheter accessing the aneurysm. The access catheter may beremoved if desired, or may be left in place. Thereafter, the introducersheath 630 is oriented at the desired orientation with respect to theaneurysm. Any of the engagement devices illustrated herein can be usedfor both delivery and retrieval of expandable components.

The delivery/retrieval member 682 is advanced through the introducersheath 630 whereby upon clearing the distal end of the introducer sheath630 the gripping elements 684 of the delivery/retrieval member 682 opento release the intrasaccular device 650. In the event the intrasacculardevice 650 is not properly positioned within the aneurysm or isdislodged, the gripping elements 684, in the open configuration, andextended beyond the introducer sheath 630, are positioned tocircumscribe the intrasaccular device 650 within the vasculature. Thedelivery/retrieval member 682 is withdrawn into the introducer sheath630 whereby the gripping elements 684 compress the foam material of theintrasaccular device 650 to permit reception of the device 650 withinthe lumen of the introducer sheath 630. Thereafter, the intrasacculardevice 650 can be removed from the neurovasculature or repositionedwithin the aneurysm by deployment of the delivery/retrieval member 682in the manner discussed herein.

FIGS. 32A-32B similarly illustrate an engagement mechanism 620 in theform of a “clover” pattern. The engagement mechanism 620 can be disposedwithin a catheter 630 and advanced distally until exiting the lumen ofthe catheter 630 at the distal end 632. Upon exiting, wire loops 640 ofthe engagement mechanism 620 can be released from engaging theintrasaccular device 650. As illustrated in FIG. 31B, when released, theintrasaccular device 650 may not tend to snag or stick to the wire loops640. Accordingly, the engagement mechanism 620 can provide fast andreliable disengagement with the intrasaccular device 650.

FIGS. 33A-33B illustrate another embodiment of an engagement mechanism670 having a “fish hook” design, similar to the engagement mechanisms324, 620 can move between closed and open positions upon exiting adistal end 632 of the catheter 630 the engagement mechanism 670 cancomprise a plurality of hooks 672 configured to pierce or otherwise atleast partially penetrate the intrasaccular device 650. Upon release,the hooks 672 can disengage from the intrasaccular device 650 in orderto release the intrasaccular device 650 into the aneurysm.

FIG. 34 illustrates an embodiment of a system in which a delivery member690 is attached to an intrasaccular device 650 using a dissolvablecoupling 692. The dissolvable coupling 692 can extend between theintrasaccular device 650 and an aperture or engagement member of thedelivery member 690. In accordance with some embodiments, engagementmember of the delivery member 690 can engage the dissolvable coupling692 using a hook, wire loop, or other elongate member, such as thosedisclosed in other delivery systems above. The dissolvable coupling 692can be actuated by chemical corrosion (e.g., electrolytic detachment),thermal corrosion, pH changes, light changes, etc. Further, thereleasable connection 692 may be effected through an electrical,hydraulic or pneumatic connection where release of the intrasacculardevice 650 is achieved through activation of any of these systems. Forexample, once the intrasaccular device 650 is positioned within theaneurysm, any of the aforementioned means may be actuated to release theintrasaccular device 650 from the delivery member 690.

FIG. 35 illustrates a microcatheter delivery system for implanting anintrasaccular device 720 within the aneurysm. A delivery system 730 cancomprise a delivery catheter 732 and pusher element 734 disposed withinthe delivery catheter 732. The intrasaccular device 720 in its normalconfiguration and predetermined geometry can be compressed andpositioned within the lumen of the delivery catheter 732.

The delivery catheter 732 may be introduced within the neurovasculatureand advanced to the treatment site. Once appropriately oriented withrespect to the aneurysm, the pusher element 734 is actuated by, e.g.,advancing a handle or actuator operatively connected to the proximal endof the pusher element 734 to cause the distal or remote end of thepusher element 734 to eject the intrasaccular device 720. Theintrasaccular device 720 can expand to pack the aneurysm.

Additionally, in accordance with some embodiments, the pusher element734 can comprise a radiopaque material or component 736 disposed on acontact member 738 of the pusher element 734. As the pusher element 734is advanced within the lumen of the catheter 732, the radiopaquematerial 736 can enable the clinician to visualize the location of theintrasaccular device 720 to ensure proper positioning of the pusherelement 734 within the lumen of the catheter 732.

FIG. 36 illustrates an alternate embodiment of the delivery system. Inaccordance with this embodiment, system 760 includes introducer sheath762 and delivery member 764 disposed within the introducer sheath 762.The delivery member 764 may be a push rod advanceable within theintroducer sheath 762. The intrasaccular device of this disclosureincludes a plurality of intrasaccular pellets 770 a, 770 b disposedwithin the introducer sheath 762 to be ejected in sequence via thedelivery member 764. For example, the plurality of pellets can comprisea framing shape, which has been compressed and folded as a framingpellet 770 a. The pellet 770 a will be the last pellet to enter theaneurysm (after pellets 770 b). Thus, the framing pellet 770 a can tendto expand so as to extend across a neck of the aneurysm (although notnecessarily touching the ostium of the aneurysm.

These intrasaccular devices or pellets 770 a, 770 b may be smaller indimension than the aforedescribed intrasaccular devices to enablemultiple and strategic deployment within the aneurysm. Any of theembodiments of the aforedescribed intrasaccular devices may beincorporated within the pellets 770 a, 770B. Further, the deliverymember 764 can incorporate one or more radiopaque materials arecomponents 772 to facilitate visualization of the location of thedelivery member 764 within the sheath 762.

FIG. 37 illustrates another delivery system 790, in accordance with someembodiments. The delivery system 790 can comprise an over-the-wiresystem having a guide member 792 comprising a guide wire lumen 794. Theguide member 792 can also comprise a delivery lumen 796 in which a pushrod 798 can be disposed for axial movement therewithin an order todeliver an intrasaccular device comprising a plurality of expandablecomponents 800. Such an embodiment can allow the system 790 to define aminimal cross-sectional profile, thereby allowing the system 790 toextend into and through very narrow vessels to treat aneurysms insmaller vessels.

FIGS. 38-42 illustrate various implementations of some of theembodiments disclosed herein. For example, FIG. 38 illustrates anintrasaccular component 820 that has been implanted into an aneurysm830. As shown, the intrasaccular component 820 comprises a shape that issubstantially an octahedron. Such a shape can be beneficial for securelyanchoring the intrasaccular component 820 within the aneurysm 830 giventhe expanding waist and tapering ends that permit the intrasaccularcomponent 820 to fit well within a berry or saccular aneurysm. Inaddition, the intrasaccular component 820 also comprises a radiopaquematerial or marker 822 for use in locating and positioning theintrasaccular component 820 within the aneurysm 830.

FIG. 39 illustrates an intrasaccular device 840 positioned within ananeurysm 830. The intrasaccular device 840 comprises first and secondexpandable components 842, 844. The first expandable component 842comprises a shape that is substantially conical or a paraboloid ofrevolution. The second expandable component 844 comprises a shape thatis substantially hemispherical. The first and second expandablecomponents 842, 844 can comprise respective first and second matingsurface 852, 854.

When initially inserted into the aneurysm, prior to expansion, both thefirst and second expandable components 842, 844 easily fit into theaneurysm 830. Upon expansion, neither the first nor second expandablecomponents 842, 844 entirely packs the aneurysm 830. Thus, if either ofthe first or second expandable components 842, 844 were positioned byitself in the aneurysm 830, significant movement and potentialherniation of the respective component could occur from within theaneurysm 830. However, as the first and second expandable components842, 844 expand within the aneurysm 830, the first and second matingsurfaces 852, 854 can cause the first and second expandable components842, 844 to become aligned within the aneurysm 830. Such alignment, asillustrated in FIG. 39, can tend to prevent dislocation of either thefirst or second expandable components 842, 844, thus securing theintrasaccular device 840 within the aneurysm 830.

According to some embodiments, an intrasaccular the first and secondmating surfaces 852, 854 can be substantially flat. However, asillustrated in FIG. 40, some embodiments can be configured such that anintrasaccular device 860, positioned within an aneurysm 830, comprisesfirst and second mating surfaces 870, 872 of first and second expandablecomponents 880, 882 can comprise an engagement mechanism 884. Theengagement mechanism 884 can comprise engagement structures, such as arecess and a corresponding protrusion, as illustrated. The engagementmechanism 884 can comprise one of a variety of structures, such as oneor more recesses and one or more corresponding protrusions, includinghemispherical, cylindrical, conical, or other such geometric matingrecesses and protrusions. Accordingly, the engagement mechanism 84 cantend to prevent slippage between the first and second mating surfaces870, 872, thus tending to cause the first and second expandablecomponents 880, 882 to function as a composite unit.

As noted above with respect to FIGS. 13-15, some embodiments of theintrasaccular device can comprise a hollow component that can beimplanted into an aneurysm. Although a plurality of hollow componentscan be implanted into the aneurysm as a system, a single hollowcomponent can also be set in place and later packed with one or moreexpandable components. Thus, the hollow component can act as a supportor framing structure having an enclosed cavity configured to receiveadditional components therein.

For example, FIG. 41 illustrates an intrasaccular device 900 in the formof a hollow expandable component 902 that is implanted into an aneurysm904 along with a plurality of expandable components 906. As shown, thehollow component 902 can be in the form of a hollow hemispherical shellthat can act as a support or framing structure for the aneurysm andadditional expandable components placed therein. The hollow component902 can have an outer surface 908 that is in contact against an innerwall 912 of the aneurysm 904. As illustrated, the contact between theouter surface 908 and the aneurysm wall 912 can be along a portion ofthe aneurysm wall 912 that has a cross-sectional profile greater thanthe size of the opening or passing profile of the neck 920 of theaneurysm 904. Further, contact between the outer surface 908 and theaneurysm wall 912 can be at least along the lower half of the aneurysm904.

In some embodiments, the outer surface 908 of the hollow component 902can contact against a first section of the aneurysm wall 912 adjacent tothe aneurysm neck 920, as well as against a second section of theaneurysm wall 912 adjacent to the aneurysm dome 918, opposite theaneurysm neck 920. For example, the aneurysm 904 or aneurysm wall 912can be considered in terms of quadrants, and the outer surface 908 cancontact at least three quadrants of the aneurysm wall 912. In someembodiments, the outer surface 908 can be caused to contact at least aportion of each quadrant of the aneurysm wall 912. The contact of theouter surface 908 against the aneurysm wall 912 can tend to secure thehollow component 902 within the aneurysm 904 to avoid dislocation orherniation of any portion of the hollow component 902 from the aneurysm904.

Referring still to FIG. 41, the expandable components 906 can beinserted or injected into a cavity of the hollow component 902 throughan aperture 910 formed in a sidewall of the hollow component 902. Theaperture 910 can be sized such that the expandable components 906 can beinserted through the aperture 910 in their compressed state, but uponexpansion, the expandable components 906 will be unable to exit throughthe aperture 910. As also illustrated, the expandable components 906 canposition themselves during expansion such that irregular shapes of thedome 918 of the aneurysm 904 can be packed. Additionally, theintrasaccular device 900 can provide a lower porosity adjacent to theneck 920 of the aneurysm 904 while having a relatively higher porosityadjacent to the dome 918.

In accordance with some embodiments, the support or framing componentcan comprise a stent that extends along a lumen adjacent to an aneurysm.The aneurysm can be a saccular or berry, wide neck, or fusiformaneurysm. For example, a stent can be used in combination with any ofthe variety of intrasaccular devices illustrated above, such as thoseshown in FIGS. 22-30 and 38-41, which are shown as treating saccularaneurysms. In some embodiments, the framing component can advantageouslysecure the intrasaccular device within a wide-neck aneurysm byfacilitating engagement with a sufficient amount of the aneurysm wall toavoid dislodgement or herniation of the device from the aneurysm intothe parent vessel.

FIG. 42 illustrates an implementation of an intrasaccular device 940 ina method for treating a fusiform aneurysm 950. As illustrated, theintrasaccular device 940 can comprise a stent 952 that extends acrossthe aneurysm 950. The stent 952 can be released at the target locationusing a catheter and any of a variety of release methods, such asballoon expansion or self-expansion.

When expanded into contact against the inner wall of the lumen 954, thestent 952 can isolate, separate, or divide the inner cavity 956 of thefusiform aneurysm 950 from a central portion of the lumen 954.

When the stent 952 is in place, at least one expandable component 960can be released into the inner cavity 956 between the inner wall of theaneurysm 950 and an outer surface 962 of the stent 952. The expandablecomponent(s) 960 can be inserted into the cavity 956 through an openingin a wall of the stent 952 (or if the stent 952 is braided, through aninterstice of the braid).

As discussed herein, the expandable component(s) 960 can have one ormore characteristics that improve the effectiveness of the intrasacculardevice 940. Further, the characteristics of the expandable component 960can be selected based on the shape or configuration of the aneurysm 950,as discussed above. As shown in FIG. 42, the expandable components canhave a specific shape to pack the cavity 956 (e.g., a sectioned spherewith a luminal void extending through the sections, thus providing aflatter cylindrically shaped surface that can abut the outer surface ofthe stent 952). However, any of a variety of other shapes can also beselected and inserted into the cavity 956.

In accordance with some embodiments, after an intrasaccular device hasbeen implanted into an aneurysm, a material such as a liquid embolic (asdiscussed above), a drug, a radiopaque material, a contrast agent, orother agent can be injected or inserted into the aneurysm. The injectionor insertion can occur prior to, concurrently with, or after expansionof the intrasaccular device within the aneurysm. As such, the materialcan be absorbed into at least a portion of the intrasaccular device orpack any remaining voids within the aneurysm around the intrasacculardevice. The injection of a liquid embolic can advantageously increasethe overall packing density of the device. FIGS. 43 and 44 illustrateembodiments in which a liquid embolic is inserted into the aneurysm incombination with an intrasaccular device.

For example, FIG. 43 illustrates that a material 980 (e.g., a liquidembolic, drug, radiopaque material, contrast agent, or other agent) isbeing inserted into an aneurysm 982 along with an intrasaccular device984. The intrasaccular device 984 can have a high porosity, which canallow the material 980 to penetrate the intrasaccular device 984.

FIG. 44 illustrates injection of a material 990 into an aneurysm 992. Asshown, the material 990 can flow into the aneurysm 982 into theinterstice is formed between expandable components of the intrasacculardevice 994. In such an embodiment, the components of the intrasacculardevice 994 can have a lower porosity such that the material 998 may nottend to penetrate the components of the intrasaccular device 994 as muchas in the embodiment illustrated in FIG. 43.

Thus, various materials can be injected or inserted into the aneurysm tosupplement or complement the treatment provided by an intrasacculardevice.

FIGS. 45-52 illustrate additional embodiments of an intrasaccular devicethat uses a support or framing component or structure in combinationwith secondary expandable components.

FIGS. 45-46 illustrates an embodiment in which an aneurysm 1000 istreated using an intrasaccular device 1100 a, which comprises a framingstructure 1102 a having a closed end 1104 and an open end 1106. In someembodiments, the framing structure 1102 a can be formed from a braidedmaterial.

In one embodiment, the closed end 1104 of the framing structure issealed via a clamp 1108, an adhesive, or may be heat welded via knowntechniques. The closed end 1104 may be inverted relative to theremaining framing structure 1102 a and depend inwardly within theinterior thereof. The open end 1106 of the framing structure 1102 a maybe in diametrical opposed relation to the closed end 1104. Theindividual filaments ends 1110 of the framing structure at the open end1106 also may be inverted and disposed within the interior of theframing structure 1102 a.

FIG. 45 depicts the introduction of the coils through the open end 1106of the framing structure 1102 a. Suitable braid materials, structures,and method for manufacturing the framing structure 1102 a are disclosedin commonly assigned U.S. Pat. No. 6,168,622 to Mazzocchi, U.S. Pat. No.8,142,456, issued Mar. 27, 2012, U.S. Patent Application Publication No.2011/0319926, filed on Nov. 11, 2010, and U.S. Patent ApplicationPublication No. 2012/0330341, filed on Jun. 22, 2011, the entireties ofeach of which are incorporated herein by reference. Braid materials mayinclude stainless steel, nitinol cobalt chromium or the like.

As shown in the embodiment of FIGS. 45-46, the framing structure 1102 acan be deployed in the aneurysm 1000 and packed with coils 1120.However, as shown in FIG. 47-49, an intrasaccular device 1100 b, 1100 c,1100 d can comprise a framing structure 1102 b, 1150, 1160 that can bepacked with at least one expandable component 1130, 1140 (e.g., a foamcomponent). The configuration, selection, and use of the expandablecomponents 1130, 1140 are discussed above and will not be repeated herefor brevity. However, any of the embodiments disclosed herein can beused in conjunction with the framing structure 1102 a. Further, inembodiments using an expandable component, such as a foam component, thefoam can advantageously provide a higher packing density compared totraditional coil packing and accomplish this in a single device.

The framing structure 1102 a, combined with coils, an expandablecomponent, or other materials, can also provide the benefit of providinggood neck coverage while preventing embolic devices from herniating intothe parent artery. Additionally, the use of such a system can alsoincrease packing volume efficiency and achieve stasis.

As illustrated, the framing structure 1102 a may provide a support orscaffold for the supplemental intrasaccular components or materials,including coils, expandable components, or other materials (e.g., aliquid embolic, drug, radiopaque material, contrast agent, or otheragent). The coils 1120 or expandable component 1130 may contain or becoated with bioactive coating that promotes specific clinical theorysuch as endothelialization, thrombosis, etc.

Referring briefly to FIGS. 50-52, these figures illustrate examples offraming structures that can be used as support or framing components,according to some embodiments. In FIG. 50, a braided device 1200 cancomprise a single-layer outer portion 1202 that is formed by inverting atubular braid such that an inner portion 1204 of the braid extendsthrough a center portion of the device 1200. Ends of the inner and outerportions 1202, 1204 meet at a first end 1206. Although the filament endsof the inner and outer portions 1202, 1204 can remain free (as tufts) orunbundled, the first end 1206 can comprise a hub or coupling device 1208that bundles the inner and outer portions 1202, 1204 together. In someembodiments, the hub or coupling device 1208 can be recessed within aninterior of the device 1200, although it is shown protruding in FIG. 50.

FIG. 51 illustrates another embodiment of a framing structure in which abraided device 1230 comprises at least one layer 1232 extending aroundthe periphery of the device 1230. In some embodiments, a single layercan be used, but multiple braided layers are also possible. The device1230 can comprise first and second ends 1234, 1236 that can be invertedor recessed into the device 1232 formed a smooth outer surface for thedevice 1230. The first and second ends 134, 136 can be open or closed.As shown, the first and second ends 1234, 1236 can comprise couplingdevices 1240, 1242, which close both ends 1234, 1236. However, one orboth of the first and second ends 1234, 1236 can also be open, such thatthe filaments ends thereof are free and unbundled.

FIG. 52 illustrates yet another embodiment of the framing structure inwhich a braided device 1250 comprises a dual layer shell 1252 having asubstantially closed end 1254 and an open end 1256. The open end 1256can be inverted or recessed into the device 1250.

Referring again to FIGS. 45-46 and 48-49, after a framing structure 1102a, 1150, 1160 has been released an expanded into contact against aninner wall of the aneurysm 1000, the procedure of implanting coils, anexpandable component, or other materials into the framing structure 1102a, 1150, 1160 can be performed by either inserting a catheter 1112, suchas a distal end 1114 thereof, between filaments of the framing structure(see FIG. 48) or into an open end of the framing structure (see FIGS. 45and 49).

In implementing a method for placing a framing structure within ananeurysm and injecting coils, expandable component(s), or othermaterials into the framing structure, the open end or widest intersticesof the framing structure can be positioned at the neck of the aneurysmso as to facilitate insertion of the distal end 1114 of the catheter1112 into the open end or between the filaments (i.e., into aninterstice) of the framing structure. In embodiments having a braidedmaterial for the framing structure, the braid pattern can be properlyaligned to facilitate entry of the materials into the framing structure.As in other embodiments disclosed herein, the framing structure cancomprise a radiopaque material or component that facilitatesvisualization and enables the clinician to align the framing structureas needed within the aneurysm.

As illustrated in FIGS. 46-47 and 49, after the coils, expandablecomponent, or other materials have been inserted into the interior ofthe braided device through its open end, the open end can collapse ontoitself or onto an inner surface of the framing structure as the coils,expandable component, or other materials settle or expand within thecavity of the framing structure. As shown in FIG. 49, the distal end1114 of the catheter 1112 can be withdrawn, thus allowing the open tubeportion 1162 to close onto itself in response to expansive forces fromthe expanding component(s) or materials. Further, in some embodiments,as illustrated in FIG. 52, an open end 1256 can define a generallytubular portion that can be deflected into contact with the inner wallof the framing structure when at least one expandable component isreleased into and expand within the cavity of the framing structure. Assuch, the open end can tend to self-seal, thus preventing herniation ofthe coils, expandable component, or other materials disposed within theframing structure.

The composite effect of the coils, expandable component, and/or othermaterials inserted into the framing structure can provide the advantagesand benefits discussed above with respect to various other expandablecomponents. As such, the clinician can determine and control variousintrasaccular implant characteristics, including porosity, composition,material, shape, size, interconnectedness, inter-engagement, coating,etc.

According to some embodiments, systems or kits having a framingstructure and at least one coil, expandable component, and/or othermaterial can be provided.

Intrasaccular implant devices and procedures for treating aneurysms canbe improved by interconnecting individual components of theintrasaccular device. According to some embodiments, a plurality ofexpandable components can be interconnected along a wire, filament, orother disconnectable or breakable material. The expandable componentscan be connected in a linear configuration (see FIGS. 53-58C), a planarmatrix (see FIGS. 59A-60B), or in a three-dimensional matrix (see FIGS.61A-61B). The expandable components of such interconnected linear,planar, or three-dimensional matrices can be sized and configured inaccordance with desired porosity, size, shape, radiopacity, or othercharacteristics disclosed herein, which will not be repeated here forbrevity.

In some embodiments, methods are provided by which interconnectedexpandable components can be released into an aneurysm. Theinterconnected components can be preconfigured (e.g., a select number ofcomponents can be removed from a larger strand or array of components)prior to implantation and later inserted into a delivery catheter.Thereafter, the entire strand or assembly of interconnected expandablecomponents of the intrasaccular device can be released into theaneurysm.

However, in accordance with some embodiments, an entire strand or arrayof components (which would, in their expanded state, exceed theavailable space in the aneurysm) can be loaded into a delivery catheter,and while implanting and observing the packing behavior, a clinician candetermine that a select portion of the interconnected expandablecomponents is sufficient for a given aneurysm. Thereafter, the selectportion of the interconnected expandable components can be broken or cutin situ so as to be released into the aneurysm.

Referring now to FIGS. 53-57C, various embodiments of linearlyinterconnected expandable components are shown. As illustrated in thesefigures, an intrasaccular device 1300 a, 1300 b, 1300 c, 1300 d cancomprise a strip of expandable components 1302 a, 1302 b, 1302 c, 1302d. The strip 1302 a, 1302 b, 1302 c, 1302 d may include spaces or breaksseparating adjacent expandable components to facilitate selectivedetachment of expandable components. The configuration of the strip 1302a, 1302 b, 1302 c, 1302 d permits the clinician to either detach adesired number of expandable components needed for the procedure beforeinitiating the procedure or detaching a desired number of components insitu. Intrasaccular devices having interconnected expandable componentscan be delivered with or without a supporting or framing structure.

The expandable components 1302 a, 1302 b, 1302 c, 1302 d may beinterconnected along one or more strings, filaments, carriers,indentations, reduced size sections, or perforation lines (which mayinclude or be devoid of a filament or string) 1304 a, 1304 b, 1304 c,1304 d. For example, FIG. 53 illustrates an intrasaccular device 1300 ahaving a plurality of indentations or 1304 a (which can also include orbe substituted by perforation lines) that separate adjacent expandablecomponents. FIG. 54 illustrates an intrasaccular device 1300 b having aplurality of expandable components that are formed or molded along afilament or string 1304 b. Further, FIGS. 55-56 can include filaments orreduced diameter expandable portions 1304 c, 1304 d that interconnectadjacent expandable components.

In accordance with some embodiments, the strings, filaments, carriers,indentations, reduced size sections, or perforation lines extendingbetween adjacent expandable components can enhance pushability of theintrasaccular device 1300 a, 1300 b, 1300 c, 1300 d into the aneurysm.

Further, as illustrated in FIGS. 57A-57C, the expandable components ofthe intrasaccular device 1300 a, 1300 b, 1300 c, 1300 d can comprise oneor more cross-sectional profiles, such as a rectangle shape 1320 (seeFIG. 57A), a square shape 1330 (see FIG. 57B), or a round, e.g.,circular, shape 1340 (see FIG. 57C). Various other cross-sectionalprofiles can be provided, such as polygons having three, five, six,seven or eight sides, star shapes, clover shapes, and the like.Additionally, a single intrasaccular device can comprise expandablecomponents that have different cross-sectional shapes or that haveidentical cross-sectional shapes, according to some embodiments.

Further, in accordance with some embodiments, consecutive expandablecomponents of an intrasaccular device 1300 a, 1300 b, 1300 c, 1300 d candescend in size, which can allow selection of a subset of the expandablecomponents of the intrasaccular device 1300 a, 1300 b, 1300 c, 1300 dbased on a specific target aneurysm size or shape.

FIGS. 58A-60B illustrate additional embodiments of intrasaccular devicesthat can have nonlinear configurations. For example, FIG. 58Aillustrates an embodiment of an intrasaccular device 1400 comprising alayer or planar array of a plurality of interconnected expandablecomponents 1402 in a compressed state, according to some embodiments.The expandable components 1402 can be interconnected by one or morestrings, filaments, carriers, indentations, reduced size sections, orperforation lines (which may include or be devoid of a filament orstring) 1406. The expandable components 1402 can have the same ordifferent shapes, sizes, or material properties as each other. Forexample, as illustrated in FIGS. 58A-58B, the intrasaccular device 1400can comprise a central expandable component 1404 having an expanded sizethat is much greater than the expanded sizes of surrounding expandablecomponents 1402. Thus, as shown in FIG. 58B, when released into ananeurysm, the intrasaccular device 1400 can expand into a configurationin which the central component 1404 is anchored in the aneurysm 1420 bythe surrounding expandable components 1402.

Similar to the embodiment illustrated in FIGS. 58A-58B, variousembodiments can be provided in which surrounding or anchoring expandablecomponents can be interconnected with other components in a matrix toenhance the fit or engagement of the intrasaccular device within ananeurysm. Further, such surrounding expandable components can havecharacteristics different from those of the central expandablecomponent, such as having coatings or other properties that beneficiallyaffect the efficacy of the intrasaccular device within the aneurysm.

FIG. 59A-59B illustrate embodiments of intrasaccular devices 1450, 1460comprising a layer, ring, or planar array of interconnected expandablecomponents 1452, 1462 in a compressed state. The expandable components1452, 1462 can be interconnected by one or more strings, filaments,carriers, indentations, reduced size sections, or perforation lines(which may include or be devoid of a filament or string) 1454, 1464. Forexample, each of the expandable components 1452, 1462 can be connectedto at least two other expandable components 1452, 1462.

FIG. 60A-60B illustrate embodiments of intrasaccular devices 1480, 1490comprising a three-dimensional or multi-planar array of interconnectedexpandable components 1482, 1492 in a compressed state. The expandablecomponents 1482, 1492 can be interconnected by one or more strings,filaments, carriers, indentations, reduced size sections, or perforationlines (which may include or be devoid of a filament or string) 1484,1494. For example, each of the expandable components 1482, 1492 can beconnected to at least two other expandable components 1482, 1492 tocreate a three-dimensional array. Similar to the layer or planar arrayshown in FIGS. 58A-59B, a three-dimensional array can have expandablecomponents that each have characteristics different from those of othercomponents, such as having coatings or other properties thatbeneficially affect the efficacy of the intrasaccular device within theaneurysm.

The advantageous features of intrasaccular devices having stripconfigurations can allow a clinician to quickly and readily assess atarget aneurysm and tailor an intrasaccular device specifically for theprocedure. The customization of an intrasaccular device strip can bedone before implantation or in situ. Further, the interconnectedness ofthe components tends to ensure that no component is lost.

FIGS. 61-63 illustrate a delivery system and procedure for delivering astrip of interconnected expandable components, according to someembodiments. As discussed, the configuration of the strip 1302 a, 1302b, 1302 c, 1302 d permits the clinician to detach a desired number ofexpandable components needed for the procedure.

Prior to initiating the implantation of an strip of interconnectedintrasaccular device, a clinician, through imaging means, can determinethe size and dimension of an aneurysm 1500. Once the dimensioning isdetermined, the clinician can determine decide upon a configuration forthe intrasaccular device or strip 1502 of interconnected expandablecomponents to be implanted. As shown in FIG. 61, the strip 1502 can bedelivered using an implant delivery assembly 1504, which can comprise acatheter 1506 and a pusher component 1508.

In some embodiments of the delivery procedure, after determining theconfiguration for the strip 1502, the clinician can prepare the strip1502 by separating any unnecessary expandable components there fromprior to inserting the strip 1502 into the delivery assembly 1504.Thereafter, the strip 1502 is then introduced within the aneurysm inaccordance with any of the aforedescribed methodologies.

However, in some embodiments of the delivery procedure, the cliniciancan load a strip 1502 into the catheter 1506 before trimming anyexpandable components from the strip 1502. The clinician can then pushthe strip 1502 out through a distal end 1510 of the catheter 1506, whichcauses the individual expandable components 1520 to begin to expandwithin the aneurysm 1500. As the expansion is taking place, theclinician can determine whether additional expandable components 1520should be deployed into the aneurysm 1500. If needed, the pushercomponent 1508 can be moved distally to urge one or more additionalexpandable components 1520 out of the catheter 1506. When it isdetermined that a sufficient number of expandable components 1520 areinserted into the aneurysm 1500, the clinician can break or separate thestrip 1502 by separating the respective expandable components 1520 viatrimming or tearing along the breaks, indentations or score lines andseparating the expandable components 1520.

The breaking or separating of adjacent expandable components can beperformed by actuating the cutting device 1540. In some embodiments, thecutting device 1540 can comprise a second catheter 1542 that is nestedwithin the catheter 1506. The second catheter 1542 can comprise a distalportion 1544 having an opening 1546 that extends from a side of thesecond catheter 1542. The distal portion 1544 can have a rounded shapethat can guide the expandable components 1520 out through the opening1546. In order to trim the strip 1502, the second catheter 1542 can beretracted proximally relative to the catheter 1506, thus causing theopening 1546 to close against the distal end 1510 of the catheter 1506,thereby severing a tie or filament extending between adjacent expandablecomponents 1520.

Thereafter, the distal portion 1544 of the second catheter 1542 can befurther withdrawn into the catheter 1506 and the delivery assembly 1504can be removed from the target site.

Many of the features discussed herein can be used with any of thedisclosed embodiments. For example, any of the embodiments can comprisean average porosity that varies spatially, any of the variety ofdisclosed shapes, any of the various disclosed materials or coatings,any of the disclosed 2-D or 3-D interconnected configurations, any ofthe disclosed inter-engagement configurations or structures, any of thedisclosed delivery systems, etc.

The apparatus and methods discussed herein are not limited to thedeployment and use of a medical device or stent within the vascularsystem but may include any number of further treatment applications.Other treatment sites may include areas or regions of the body includingany hollow anatomical structures.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to mean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable (or possess every advantage that is achievable)by different embodiments of the disclosure in order to be encompassedwithin the scope of the disclosure. The use herein of “can” andderivatives thereof shall be understood in the sense of “possibly” or“optionally” as opposed to an affirmative capability.

What is claimed is:
 1. A device for treatment of an aneurysm,comprising: a foam component having first and second sections, the firstsection having an average porosity different from an average porosity ofthe second section, the component being expandable from a compressedconfiguration to an expanded configuration when released into ananeurysm from a catheter.
 2. The device of claim 1, wherein the firstsection comprises a first material and the second section comprises asecond material different from the first material, the first and secondsections being coupled to each other.
 3. The device of claim 1, whereinthe component further comprises a third section coupled to the secondsection, the third section having an average porosity different from theporosity of the second section.
 4. The device of claim 3, wherein thesecond section comprises a second material and the third sectioncomprises a third material different from the second material.
 5. Thedevice of claim 3, wherein the third section porosity is different fromthe first section porosity.
 6. The device of claim 5, wherein the firstsection comprises an average porosity of between about 1 μm and about150 μm, and the third section comprises an average porosity of between150 μm and about 300 μm.
 7. The device of claim 1, wherein in theexpanded configuration, the component comprises a substantiallyspherical shape that is divided crosswise into the first and secondsections.
 8. The device of claim 1, wherein the component furthercomprises an expansion-limiting coating configured to control anexpansion rate of the component.
 9. The device of claim 1, wherein thefirst section comprises an average porosity of between about 1 μm andabout 100 μm, and the second section comprises an average porosity ofbetween about 100 μm and about 200 μm.
 10. The device of claim 1,wherein a shape of the component is selected from the group consistingof cylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.
 11. Thedevice of claim 10, further comprising a second foam component having ashape selected from the group consisting of spheres, cylinders,hemispheres, polyhedrons, prolate spheroids, oblate spheroids, plates,bowls, hollow structures, clover shapes, non-spherical surface ofrevolution, and combinations thereof.
 12. The device of claim 11,wherein the foam component and the second foam component are differentsizes from each other.
 13. The device of claim 11, wherein the foamcomponent and the second foam component are different shapes from eachother.
 14. The device of claim 11, wherein the foam component and thesecond foam component have mating structures configured to abut eachother in a complementary configuration and restrict at least degrees offreedom of motion of each of the foam component and the second foamcomponent.
 15. A system for treatment of an aneurysm, comprising: aplurality of foam components being expandable from a compressedconfiguration to an expanded configuration when released into ananeurysm from a catheter, each of the plurality of components having anaverage porosity that is different from an average porosity of anotherof the plurality of components, the plurality of components beingpositionable within the aneurysm to form a composite foam componenthaving a composite porosity configured to provide a therapeutic effect.16. The system of claim 15, wherein each of a first group of theplurality of components comprises a first average porosity, and each ofa second group of the plurality of components comprises a second averageporosity different from the first average porosity.
 17. The system ofclaim 16, wherein the first average porosity is between about 1 μm andabout 100 μm, and the second average porosity is between about 100 μmand about 200 μm.
 18. The system of claim 15, wherein a shape of atleast one of the plurality of components is substantially spherical. 19.The system of claim 15, wherein a shape of at least one of the pluralityof components is selected from the group consisting of spheres,cylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.
 20. Thesystem of claim 15, wherein each of the plurality of components isdifferent sizes from another of the plurality.
 21. The system of claim15, wherein each of the plurality of components is different shapes fromanother of the plurality.
 22. The system of claim 15, wherein a first ofthe plurality of components and a second of the plurality of componentshave mating structures configured to abut each other in a complementaryconfiguration and restrict at least degrees of freedom of motion of eachof the first and second of the plurality of components.
 23. A device fortreatment of an aneurysm, comprising: a foam component having a regionof variable average porosity and a radiopaque marker, the marker beingvisible under imaging and positionable relative to the region so as tofacilitate identification and orientation of the component whenimplanted into the aneurysm from a catheter, the component beingexpandable from a compressed configuration to an expanded configurationwhen released into the aneurysm.
 24. The device of claim 23, wherein theregion comprises a first section and a second section having an averageporosity different from an average porosity of the first material. 25.The device of claim 24, wherein the region further comprises a thirdsection adjacent to the second section, the third section having anaverage porosity different from the porosity of the second section. 26.The device of claim 25, wherein the third section porosity is differentfrom the first section porosity.
 27. The device of claim 23, wherein theregion comprises a first material and a second material different fromthe first material, the first and second materials being coupled to eachother.
 28. The device of claim 23, wherein the marker comprises amaterial blended into the component such that the component is visibleunder imaging.
 29. The device of claim 23, wherein the marker is coupledto an exterior of the component.
 30. The device of claim 23, wherein ashape of the component is selected from the group consisting ofcylinders, hemispheres, polyhedrons, prolate spheroids, oblatespheroids, plates, bowls, hollow structures, clover shapes,non-spherical surface of revolution, and combinations thereof.
 31. Thedevice of claim 30, further comprising a second foam component having ashape selected from the group consisting of spheres, cylinders,hemispheres, polyhedrons, prolate spheroids, oblate spheroids, plates,bowls, hollow structures, clover shapes, non-spherical surface ofrevolution, and combinations thereof.
 32. The device of claim 31,wherein the foam component and the second foam component are differentsizes from each other.
 33. The device of claim 31, wherein the foamcomponent and the second foam component are different shapes from eachother.
 34. The device of claim 31, wherein the foam component and thesecond foam component have mating structures configured to abut eachother in a complementary configuration and restrict at least degrees offreedom of motion of each of the foam component and the second foamcomponent.
 35. A method for treatment of an aneurysm, comprising:advancing a foam component through a catheter lumen, the componentcomprising a first section having a different average porosity than anaverage porosity of a second section; releasing the component into theaneurysm; allowing the component to expand from a compressedconfiguration to an expanded configuration within the aneurysm; andpositioning the component within the aneurysm such that the firstsection is positioned away from the aneurysm neck and the second sectionis positioned adjacent to a neck of the aneurysm.
 36. The method ofclaim 35, wherein the positioning comprises rotating the component. 37.The method of claim 35, wherein the positioning comprises maintaining aposition of the component relative to the aneurysm neck during expansionto the expanded configuration.
 38. The method of claim 35, wherein theaneurysm is disposed adjacent at bifurcation of a parent vessel into twoefferent vessels, and wherein the positioning further comprisespositioning the second section adjacent to the bifurcation andpermitting flow through the bifurcation and into at least one of thefirst or second efferent vessels.
 39. The method of claim 35, whereinthe component further comprises a third section disposed between thefirst and second sections, the third section having an average porositydifferent than the porosity of the second section, wherein thepositioning comprises positioning the component such that the firstsection is positioned at a fundus of the aneurysm and the third sectionis positioned between the fundus and the aneurysm neck.
 40. The methodof claim 35, further comprising injecting a liquid embolic material intothe aneurysm after positioning the component.
 41. The method of claim35, further comprising implanting a support structure into the aneurysmbefore releasing the component into the aneurysm, and wherein thereleasing comprises releasing the component through a wall of thesupport structure into the aneurysm.
 42. The method of claim 41, whereinthe support structure comprises a substantially enclosed interiorcavity, and the releasing further comprises releasing the component intothe interior cavity.